The White House Office of Management and Budget released their 2016 rule agenda at the close of last year, laying out some of the goals they have for releasing final and proposed rules over the next year. In that agenda, revisions to three healthcare fraud and abuse rules are planned, including one that would increase the Office of Inspector General's ability to impose civil monetary penalties.
Three Rules for Office of Inspector General
Rule Number 0936-AA04, the rule affecting the OIG's Civil Monetary Penalty Rules, implements authority under the Affordable Care Act and authorizes Centers for Medicare and Medicaid Services to assess new penalties. CMS will be permitted to assess fines for failing to grant timely access to the OIG; for ordering and prescribing while excluded; for making false statements, omissions, or misrepresentations in an enrollment application; for failing to return an overpayment; or for making or using a false record or statement that is material to a false or fraudulent claim. The rule also aims to add clarity to the regulatory scheme and provide a blueprint for how to make regulations more accessible to the public. This rule is set to have final action taken by May 2016.
Rule Number 0936-AA05 focuses on Fraud and Abuse, and includes some revisions to the OIG's Exclusion Authorities. As you may recall, the Affordable Care Act expanded the OIG's authority to protect Federal health care programs from fraud and abuse. This Rule will update OIG regulations to codify the changes made by the Affordable Care Act, while also updating and clarifying the regulations pursuant to the Medicare Prescription Drug Improvement and Modernization Act of 2003. This rule will have final action taking place in May 2016.
The last of the three rules set to affect OIG this year by the Office of Management and Budget is Rule Number 0936-AA06. This Rule will amend the safe harbors to the anti-kickback statute and civil monetary penalty rules under the authority of the OIG. This final rule will ad some new safe harbors, some of which codify statutory changes set forth in the Medicare Prescription Drug Improvements and Modernization Act and the Affordable Care Act. The new safe harbors were created to protect certain payment practices and business arrangements from criminal prosecution and civil sanctions under the kickback provisions of the statute. This Rule will also codify the Affordable Care Act's revised definition of "remuneration" and add a gainsharing civil monetary penalty provision. This rule will have Final Action taken by June 2016.
Bonus Rule: Centers for Medicare and Medicaid Services
Another rule set to be released in 2016 is the final version of the sixty-day overpayments rule. The rule will require providers to return overpayments and to notify the agency that the payment was returned within sixty days of first identifying the overpayment. This rule will apply to Medicare Part A and B providers as well as suppliers.
The rule also provides for a ten-year "look back" period on claims that are not identified by a provider. The "look back" period has been harshly criticized from industry participants, arguing that the agency is "overstepping its statutory authority," in part because it conflicts with look back periods for Part C and D overpayments, which are significantly shorter.
This rule was originally slated to go into effect in February 2015, but was pushed back due to "exceptional circumstances" revolving around the rule's complexity and the volume of public comments received. While the rule being pushed back may seem like a positive move, providers and suppliers still must give back overpayments, whether the final rule is in effect or not. Penalties can now include potential False Claims Act liability carrying fines as high as $10,000 per unreturned overpayment and future exclusion from Medicare.
These agenda items and final rules are in addition to the HHS agenda items we have previously written about.