Manatt Provides Input to OIG on Opportunities for Modernizing Guidance Mechanisms

Health Highlights

On January 31, 2022, Manatt, Phelps & Phillips, LLP, submitted a formal response to the Request for Information (RFI) issued by the U.S. Department of Health & Human Services, Office of Inspector General (OIG) on ways to make its publicly available resources more relevant, timely and user-friendly.1 OIG’s resources—including advisory opinions, Special Fraud Alerts (SFAs), Special Advisory Bulletins (SABs) and Compliance Program Guidance documents—provide essential guidance to health care stakeholders when it comes to promoting compliance with the federal fraud and abuse laws, structuring effective compliance programs, and other topics. Given the significant passage of time since many of OIG’s resources were initially published, and the continued rapid evolution of the health care industry, OIG issued the RFI to launch what the agency anticipates will be a multistep, multiyear process to streamline, revise and improve its existing guidance mechanisms. Through the RFI, OIG sought to gather input on how best to prioritize and approach its modernization efforts.

Manatt’s submission was informed by the firm’s collective experience working with clients across all segments of the health care industry, including hospitals and health systems, physician practices, post-acute care companies, and other providers and suppliers; pharmaceutical, medical device, digital health and other life sciences companies; health plans; and state Medicaid programs. In addition, Manatt conducted a series of interviews with clients of all sizes and levels of maturity, ranging from large, well-established health care companies to smaller startup companies. Such client feedback informed, and was incorporated into, the submission on an anonymous basis.

A taste of the suggestions and key points from Manatt’s RFI response includes the following:

  • OIG Advisory Opinions: To address the often prohibitively long wait time for issuance of an advisory opinion, Manatt expressed support for an optional short-form advisory opinion process. This would allow requesting parties to quickly receive a binding answer to the material question as to whether OIG would seek to impose administrative penalties, while preserving the ability to request and have the benefit of OIG’s more fulsome analysis of the underlying arrangement via a traditional long-form advisory opinion if desired. Manatt also encouraged OIG to consider a tiered fee structure for advisory opinion requests, borrowing from the Food & Drug Administration’s drug and device user fee models. The goal of this new model would be to provide greater predictability to requesting parties around the cost of an advisory opinion, as well as to secure commitments from OIG to issue advisory opinions within defined timeframes in exchange for preset fees. 
  • Special Fraud Alerts and Special Advisory Bulletins: To maximize the relevance and usefulness of SFAs and SABs, Manatt proposed that OIG consider committing to the publication of a new such document every quarter or semiannually. Because False Claims Act cases and OIG investigations may remain under seal or otherwise nonpublic for several years, issuance of SFAs or SABs in close to real time—as OIG identifies relevant risk areas—would be more helpful to the industry than issuing such documents once an enforcement pattern has emerged around a particular type of conduct. Manatt also encouraged OIG to adopt a formal mechanism for retiring guidance documents that potentially have led to unnecessary industry confusion or that are no longer relevant. 
  • Frequently Asked Questions: Finally, Manatt indicated strong support for the creation of a formal Frequently Asked Questions (FAQ) process. This would be patterned after the limited FAQ process OIG has developed to address the application of OIG’s administrative authorities to arrangements directly connected to the COVID-19 pandemic. The creation of such an FAQ process would provide an accessible pathway for parties to seek feedback from OIG outside the rigorous contours of the advisory opinion process and on topics that may not be arrangement-specific (e.g., general compliance best practices, scenarios involving the effect of exclusion from participation in the federal health care programs). 

Industry stakeholders should be attuned to other OIG efforts to solicit feedback as part of this important modernization initiative in the coming months. To view Manatt’s full comments to OIG in response to the RFI, please click here.

1 85 Fed. Reg. 53,072 (Sept. 24, 2021).



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