In a March 11 advisory opinion the Department of Health and Human Services’ Office of Inspector General (“OIG”) permitted a medical device manufacturer to pay Medicare-reimbursable costs for subjects enrolled in a clinical trial sponsored by the manufacturer and involving the manufacturer’s therapy.
The OIG indicated it would not impose administrative sanctions, despite the fact
On July 1, 2021, the Department of Justice (DOJ) released a memorandum signed by Attorney General Merrick Garland regarding the issuance and use of guidance documents. Addressed to the heads of all DOJ components, the memorandum rescinds two previous DOJ memoranda and outlines the principles governing the DOJ’s revised approach in evaluating guidance documents.
2017 Memorandum
On November 16, 2017, then Attorney General Jeff Sessions published a memorandum entitled “Prohibition on Improper Guidance Documents” (the “2017 Memorandum”). The 2017 Memorandum sought to address instances in which guidance documents published by the DOJ were being used to “effectively bind private parties without undergoing the [notice-and-comment] rulemaking process.” Under the 2017 Memorandum, Attorney General Sessions prohibited publication of guidance documents “that purport to create rights or obligations binding on persons or entities outside the Executive Branch (including state, local and tribal governments).” The 2017 Memorandum directed the DOJ to also adhere to several principles in constructing and publishing guidance documents. These included avoiding the use of mandatory language, specifically noting that voluntary standard non-compliance would not result in enforcement action and including unambiguous statements that published guidance documents were not legally-binding final agency actions.
Brand Memo
Following the 2017 Memorandum, then Associate Attorney General Rachel Brand released a memorandum entitled “Limiting Use of Agency Guidance Documents In Affirmative Civil Enforcement Cases” (the “Brand Memo”). The Brand Memo built upon the publication principles outlined in the 2017 Memorandum and extended them to the DOJ’s legal actions, preventing DOJ lawyers from utilizing non-compliance with guidance documents as a basis for filing a civil lawsuit. While DOJ lawyers could still use guidance documents read by a party as evidence that such party had knowledge of a legal mandate, “that a party fails to comply with agency guidance [documents] expanding upon statutory or regulatory requirements does not mean that the party violated those underlying legal requirements.”Continue Reading DOJ revises approach to publication and enforcement of guidance documents