In a notice published on May 12, 2014, the Office of Inspector General (OIG) proposed changes and clarifications to regulations governing health care fraud and abuse and Civil Monetary Penalties (CMPs). In addition to a general reorganization of the regulations for clarity, the Proposed Rule includes new categories of conduct for which OIG may impose penalties, assessments, and exclusions, and it broadens the liability of health care organizations for the actions of their agents to include contractors and suppliers. The suggested rule change also clarifies aggravating and mitigating factors the OIG will consider in determining sanctions. These changes would broaden the OIG’s authority to impose CMPs and are likely to result in higher penalties.
New Proscribed Conduct
The Patient Protection and Affordable Care Act (ACA) amended the CMP laws to include the following additional conduct for which sanctions may be imposed:
These additions expand health care providers’ potential liability for CMPs.
Factors for Determining Sanctions
The OIG proposes adding the following list of primary factors it will consider to determine the amount of CMPs and length of exclusion for violations:
These non-exhaustive factors would apply to all CMP violations unless otherwise stated; individual sections may also provide further explanation of a factor’s relevance and application to a particular subject matter, including its treatment as an aggravating factor.
Changes to Aggravating and Mitigating Factors
In addition to new proscribed conduct, changes to aggravating and mitigating factors may increase the likelihood of higher penalties for violations. The Proposed Rule would increase the claims-mitigating factor from $1,000 to $5,000 to reflect that an amount under $5,000 suggests less serious conduct; the claims-aggravating factor would be set at $15,000 or more (from the current “substantial” amount). Despite this increase to the mitigating amount and clarification to the aggravating figure, the addition of new aggravating factors could still expose practitioners to higher CMPs. Further aggravating factors include:
The Proposed Rule also clarifies that the presence of even one aggravating factor may justify the maximum allowable CMP amount and would require exclusion.
CMPs for Retaining Overpayments and Engaging Excluded Persons or Entities
The Proposed Rule clarifies that the default CMP Law’s penalty of up to $10,000 applies to failures to report and return an overpayment. The deadline for return of an overpayment without penalty is the later of 60 days from when the overpayment was identified or from when a corresponding cost report was due. The $10,000 CMP would apply to every day beyond the applicable 60-day period. In the case of provider liability for employing excluded persons for non-separately billable services, the OIG proposes a new "per-day penalty" methodology based on the number of days that a penalized provider employed, contracted with, or otherwise arranged for an excluded person to provide non-separately billable items or services.
CMPs for EMTALA Violations
The revised regulation would also clarify that an on-call physician would be liable for failing or refusing to report to the hospital for the examination, treatment, or transfer of a patient within a reasonable amount of time from being summoned. A physician on-call for a hospital with specialized capabilities or facilities would also be subject to CMPs for refusing an appropriate patient transfer or similarly failing to report to receive a transfer.
CMPs for Adverse Action Reporting and Peer Review Disclosure Violations
The proposed change to this section would remove current references to the Healthcare Integrity and Protection Data Bank (HIPDB), as this system is being phased out and will merge into the National Practitioner Data Bank. This revision would not, however, change the reporting requirements. The regulation would further clarify that CMPs may be imposed for each failure to report an adverse action or other required information and for each improper disclosure, use, or permitting of access to reportable information.
Appeals of Exclusions, Civil Monetary Penalties, and Assessments
This section would clarify that a person must exhaust all administrative remedies before seeking review by a federal court and that, absent “exceptional circumstances,” claims must be raised at every stage of the administrative process in order to be reviewable. Finally, the OIG seeks to clarify that an Administrative Law Judge (ALJ) may not review an exercise of the OIG’s discretion to exclude an individual or entity, decide the scope or effect of an exclusion, or establish an exclusionary period of zero when the ALJ find that a violation occurred.
Should you have any questions related to CMP regulations or the effects of the Proposed Rule, please contact Peter Mellette (Peter@mellettepc.com), Harrison Gibbs (Harrison@mellettepc.com), or Nathan Mortier (Nathan@mellettepc.com) or call Mellette PC at (757) 259-9200. Comments on the proposed regulations are due by July 11, 2014.
 The National Practitioner Data Bank may be accessed at http://www.npdb.hrsa.gov/
Mellette PC acknowledges with appreciation Caitlin Riccobono ’15 (University of Richmond Law School) for her assistance in preparing this advisory.