The Department of Health and Human Services Office of Inspector General (OIG) has been busy lately with proposed rules aimed at fraud and abuse. Last week, OIG proposed to expand their exclusion authorities. On May 12th, OIG announced a plan to broaden the list of offenses that could earn providers civil monetary penalties (CMPs). Now providers who fail “to grant OIG timely access to records” could be hit with a $15,000 penalty “for each day of failure to grant timely access.”
The OIG currently may seek CMPs for a wide variety of conduct, including against anyone who:
- Presents or causes to be presented claims to a Federal health care program that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent.
- Violates the anti-kickback statute by knowingly and willfully: (1) offering or paying remuneration to induce the referral of Federal health care program business; or (2) soliciting or receiving remuneration in return for the referral of Federal health care program business.
- Presents or causes to be presented a claim that the person knows or should know is for a service for which payment may not be made under the physician self-referral or “Stark” law.
Under the proposed law, OIG expands on this list to include:
- Failure to grant OIG timely access to records;
- Ordering or prescribing while excluded;
- Making false statements, omissions, or misrepresentations in an enrollment application;
- Failure to report and return an overpayment; and
- Making or using a false record or statement that is material to a false or fraudulent claim.
OIG also plans to reorganize 42 CFR 1003—the regulations dealing with CMPs. Right now, the regulations are confusing and scattered. OIG notes: “Separate sections discuss the penalty and assessment amounts, exclusion provisions, the factors for determining the appropriate penalty and assessment amounts, and the factors for determining whether OIG should impose exclusion.” OIG has set about to change this “cumbersome” structure through organizing the regulations by subject matter.
Additionally, the proposed rule seeks to “add clarity and improve transparency to OIG’s decision-making process.” They have a section entitled “Determinations regarding the amount of penalties and assessments and the period of exclusion,” which lists the factors OIG will consider in dolling out CMPs.
The primary factors are: (1) The nature and circumstances of the violation, (2) the degree of culpability of the person, (3) the history of prior offenses, (4) other wrongful conduct, and (5) other matters as justice may require. “As the fifth factor demonstrates,” OIG notes “these are illustrative factors rather than a comprehensive list.” Furthermore, OIG proposes to revise the claims-aggravating factor by replacing ”substantial” with ”$15,000 or more.”
Future Proposals
In the proposed rule, OIG contemplates additional rulemaking in the following areas: Exclusion authorities (which we recently covered here); inflation adjustment for CMPs (42 CFR part 1003); and safe harbors under the anti- kickback statute, a revised definition of remuneration in part 1003, and a codified “gainsharing CMP” (42 CFR 1001.952, 42 CFR part 1003). OIG states: “Each of the proposed rules is a stand-alone, independent rule, and the public need not wait for all of the proposed rules to be published to submit comments on any one of the proposed rules. Thus, one can comment meaningfully on this proposed rule without having seen the proposed rules concerning exclusion authorities, inflation adjustment for CMPs, or safe harbors under the anti- kickback statute.”
Public Comments
OIG has already settled with 20 providers in 2014 alone. Many have agreed to pay hundreds of thousands of dollars for allegedly violating the Civil Monetary Penalties Law. The proposed regulations, if adopted, would likely cause that number grow.
To ensure consideration, comments must be delivered to the address provided below by no later than 5 p.m. Eastern Standard Time on July 11, 2014.
In commenting, reference file code OIG–403–P.
Electronically. You may submit electronically through the Federal eRulemaking Portal at http://www.regulations.gov. (Attachments should be in Microsoft Word, if possible.)
By regular, express, or overnight mail. You may mail your printed or written submissions to the following address: Patrice S. Drew, Office of Inspector General, Department of Health and Human Services, Attention: OIG– 403–P, Cohen Building, 330 Independence Avenue SW., Room 5541C, Washington, DC 20201.