Get to work now. Can the latest General Compliance Program Guidance help strengthen your compliance plan? The answer is yes, if you use the guidance document to assess and align your current efforts. The HHS Office of Inspector General “intends for members of the healthcare sector to use the GCPG for purposes of creating and maintaining an appropriate compliance program,” attorneys with law firm McGuire Woods advise in recent online analysis of the document. “This content will help healthcare providers and other industry participants to strengthen their compliance programs and reduce the risk of a government investigation or enforcement action,” they say. The GCPG should be more than a general resource. It should become an invaluable tool to help you complete the puzzle of understanding, developing and maintaining an effective healthcare compliance program, experts urge. Then: In the late 1990s, the OIG first recommended healthcare compliance programs to help providers comply with applicable federal laws and regulations. Since then the OIG has created a variety of compliance resources — advisory opinions, industry-specific Compliance Program Guidances (CPGs), open letters, special Fraud Alerts and more. The OIG issued the first CPGs for home health back in 1998 and hospice in 1999. In April 2023, the OIG announced plans to improve and modernize existing guidance to deliver one comprehensive document for all providers (see HHHW by AAPC, Vol. XXXII, No. 15). Its goal was to produce more timely and useful resources to help advance the industry’s voluntary compliance efforts in preventing fraud, waste, and abuse. Now: As of November 2023, the watchdog agency completed its initial step with the GCPG document. Know this: The GCPG is not binding. It is voluntary guidance that discusses general compliance risks and compliance programs. The GCPG includes compliance program guidance directed at many types of healthcare organizations including home health agencies and hospices, as well as hospitals, nursing facilities, physicians, DMEPOS, third-party medical billing companies, and others. The document outlines the infrastructure to maintain or strengthen and improve your compliance program, including adaptations for different size entities. It also proposes incentives for compliance and encourages adding other compliance concerns to your program. Since the beginning, the OIG has advocated seven core elements for a strong healthcare compliance programs (see box, this page). It reinforces those tenets with action items. Adapt For Size The OIG covers small and large entity adaptations, including concrete suggestions for: Small entity variables include designation of a compliance contact when a full-time compliance officer is not possible, using existing or template policies and procedures and training materials, and offering an ‘open door’ policy in lieu of a formal communication program. Large and more complex entity variables include considerations for a compliance department comprised of staff with a variety of skills and expertise. For example, an organization that operates or controls a variety of providers and suppliers such as HHAs providing rehabilitation therapy services and hospices should ensure that the compliance department has the knowhow to address the compliance risks for each of these components. The OIG also recommends creating subcommittees under the oversight of the Compliance Committee to provide support, and staffing those subcommittees with a mix of Compliance Committee members and subject matter experts. Finally it suggests separate board committees, such as a Board Audit Committee and a separate Board Compliance Committee, with a charter specific to healthcare compliance. New Emphasis On Incentives In a major shift, the OIG now encourages companies to devote time, thought, and creativity to compliance activities and contributions that the entity can reward. “This new concept advocates for the use of creative ways to incentivize,” attorney Melissa Wong with law firm Holland & Knight observes in online analysis. “The incentive can be the basis for additional compensation, significant recognition or other, smaller forms of encouragement,” Wong offers. At the same time, “incentive plans generally should be reviewed to ensure that they can be achieved while operating in an ethical and compliant manner,” she cautions. The OIG suggests behavior that entities may want to incentivize including: The OIG recommends you reduce or eliminate potential fraud and abuse risks in other areas as well including: 1. Quality and patient safety — includes adding individuals responsible for quality assurance and patient safety to compliance committees, and incorporating oversight in these areas for not only patient harm, but medically unnecessary or excessive services.
2. New risk areas — encourages steps to ensure business partners possess a solid understanding of federal fraud and abuse laws and evaluation and risk assessment of new and different lines of business including: 3. Financial Incentives: Ownership and Payment — scrutiny of operations and incentive structures including risks associated with payment incentives from reimbursement of items and services provided, as well as financial arrangements and transactional agreements, including those between referral sources and referral recipients. Ensure compliance as well as deliverance of high quality, safe care. Old: The GCPG advises that existing OIG compliance and legal resources will remain on its website. This includes related documents as well as bulletins, FAQs, toolkits, videos, podcasts, and other guidance material. New: It also reveals that new or updated guidance will no longer appear in the Federal Register. Look to its site for all future compliance announcements. Do this: “We recommend each organization, either with existing compliance programs or those in the developmental stage, comprehensively review the GCPG and reference it when assessing whether your current program conforms with OIG’s expectations,” attorneys Ritu Kaur Cooper, Katherine Kuchan, and Scott Taebel with law firm Hall Render say in online analysis. “It would behoove any organization to reevaluate their compliance program to ensure it is aligned with the GCPG and any forthcoming recommendations from OIG.” Next Step: The OIG anticipates publishing the first two industry segment-specific CPGs (ICPGs) in 2024, beginning with Medicare Advantage and nursing facilities, then hospitals and clinical laboratories. So, home health and hospice ICPGs may not be far behind. Note: See the OIG’s compliance resources including the GCPG at https://oig.hhs.gov/compliance/.