Although much has been made of wide audiences and expenditure review with the Patient Protection and Affordable Care Act (“PPACA”), almost unnoticeable mandate has put some doctors on edge. No, this is not a reference to either the individual or employer mandate insurance or other insurance reforms, although the time doctors need to have solutions for these issues as well. Rather, the new requirement states that must approve binding compliance programs.
Compliance programs are hardly a new thing in healthcare. Before PPACA healthcare or suppliers with federal contracts (ie, Medicare, Medicaid and / or CIHP) of $ 5,000,000 were required to have such a program in effect. However, with the emergence of PPACA is now mandates that all provider involved in the Medicare or Medicaid program will, as a condition of enrollment, have been a plan in place – regardless of size is available. But while the new law offers little guidance to providers how to structure or what to put in such a program, we are able to take evidence from previous federal regulations as a necessary part of it will be. Physician groups are urged to start putting such plans in place, and this paper goes into some of the essential pieces needed to be.
The Legal Character
As noted above, Section 6401 (8) PPACA says a provider of physicians other items or services or supplier must establish a compliance program. However, this is as accurate as the law gets. Following this provision, the law authorizes the secretary of HHS, in conjunction with the HHS Inspector General, to the core elements for the program. In addition, PPACA also allows a registrar to determine the time line for execution. The practical net effect of these three provisions means mandatory compliance programs are indeed a reality, but we have to wait for the normal agency rulemaking processes before we know what specifically will be included in the data. The good news is that we can look to a couple of places to get an idea of what the compliance program must comprise.
first place we can see what HHS probably require is actually PPACA itself. Section 6102, amended by section 1128 (I), addresses the reporting requirements for skilled nursing. Within this section the law mandates a similar program, but in contrast to 6401 provides the actual requirements of the program. Eight required components for the skilled nursing compliance program are:
– The program must be reasonably able to attract criminal, civil and administrative violations.
– Specific high profile individuals should be assigned the responsibility to monitor and must have sufficient resources to do so.
– The Agency shall use, taking care to include the power to individuals with predisposition to engage in violations.
– The Agency shall take steps to disseminate standards and procedures to all employees.
– The Agency shall make reasonable efforts to achieve compliance with the standards.
– The standards shall be consistently implemented by appropriate penalties.
– If the violation, the organization must take all reasonable steps to an appropriate response and prevent future offenses.
– The organization shall periodically review the re-evaluation of the compliance program
Because this provision covers skilled nursing facilities, physicians using this guidance should proceed with caution .. Once requirements are general enough that things should at least give doctors a good idea of what they should include in their own programs. And for what it’s worth, a possible explanation as to why this and not present section would clearly set out the requirements could be that this was one of the sections amended by the reconciliation bill.
Doctors have another (albeit dated) Act guidepost to use, so-called “7 key elements more programs.” Originally introduced ten years OIG regulation introducing voluntary compliance programs, are key elements:
– Maintain internal control and audit.
– Implementing compliance and practice standards.
– designating a compliance officer or contact.
– Keep proper training and education.
– Responding appropriately to detected violations and develop improvements.
– Developing open lines of communication.
-. Enforcing disciplinary standards through well-publicized guidelines
And despite the relative age of the Key Elements have been trusted for years by physician practices that chose to implement more programs. Furthermore, the rules were recently reviewed by the RAC just last May
Looking through both lists providers will clearly see the similarities between the two. We believe doctors should be pretty sure that adopt compliance program that includes all these instructions. Doctors already had programs in place for PPACA also have no need to worry. In extreme cases HHS was to loosen rules that significantly deviated from the two examples, they would surely give physician groups enough time to implement the changes in their own programs.
Some providers were understandably frustrated when learning of the new law mandating more programs – mainly due to the ambiguousness of the law, and not so much commission itself. Nevertheless, with past and current guidance and HHS OIG, providers with existing programs should not have much difficulty adapting to the upcoming regulations. In like vein, solo or smaller physician groups should not worry about a perceived lack of guidance, although we encourage still they begin the drafting process sooner rather than later.