October 4, 2010

The time is now to focus on compliance! Having an effective compliance program has never been more important. While previously, the adoption and implementation of a compliance plan was “voluntary” for physician practices and other providers in most states, The Patient Protection and Affordable Care Act of 2010 (“PPACA”), mandates that from a federal standpoint that providers and suppliers adopt a compliance program containing certain “core elements” as a condition of Medicare enrollment.

A Proposed Rule was issued on September 23, 2010, which sets forth the core elements that should be included in physicians’ compliance plans. Specifically, the Proposed Rule proposes that physician’s compliance plans contain the following elements (comprised of the elements described in the U.S. Federal Sentencing Guidelines Manual):

• A physician practice must develop and distribute written policies, procedures and standards of conduct to prevent and detect inappropriate behavior;
• A physician practice must designate a chief compliance offer (and other appropriate bodies) to operate and monitor the compliance program. The compliance officer and/or other governing body must report to high level personnel; 
• The physician practice must use reasonable efforts not to include any individual in a position of authority that the organization knew or should have known has engaged in illegal activities or conduct inappropriate for an individual in such a position; 
• The physician practice must develop and implement regular and effective education and training programs for the governing body, all employees and agents, as appropriate; 
• The physician practice must maintain a complaint process, which protects the anonymity of complainants and protects whistleblowers from retaliation; 
• The physician practice must develop a system to respond to allegations of improper conduct and enforce appropriate disciplinary action against employees who have violated internal compliance policies, statutes, regulations and Federal health care program requirements; and 
• The physician practice must use audits and/or other evaluation techniques to monitor compliance and reduce identified problem areas; and 
• The physician practice must investigate and remedy identified systemic problems, including making any necessary modifications to the organization’s compliance and ethics program.

The Proposed Rule solicits comments “concerning how the industry views compliance program elements and how [CMS] can establish required compliance program elements to protect Medicare, Medicaid and CHIP from fraud and abuse.” Such comments must be received by November 16, 2010. CMS wishes to consider such comments before finalizing its compliance program requirements. After reviewing the comments received, CMS has stated its intention to “do further rulemaking on compliance plan requirements and will advance specific proposals at some point in the future.”

Despite the fact that the Proposed Rule has yet to be finalized, the above-referenced elements are a good starting point for physicians to begin to develop a compliance plan, if they have not already done so. It may be a good time for anesthesia practices to revisit their policies as it relates to key billing and documentation compliance areas, including but not limited to: (a) anesthesia start and stop time protocols; (b) compliance with medical direction requirements; (c) documentation of medical direction and other documentation protocols; and (d) medical necessity issues. We will continue to keep you apprised as to the status of the compliance regulations.

Sincerely,

Tony Mira
President and CEO