David Cade, AHLA CEO, speaks to Brenna Jenny, Deputy General Counsel and CMS Chief Legal Officer, U.S. Department of Health and Human Services, about Executive Order No. 13891. They discuss what the order requires, what’s in HHS’ proposed rule implementing the order, and how the rule would affect HHS operations. The podcast also covers what sort of input the agency is seeking from stakeholders in response to its RFI issued last month. The comment deadline for the RFI was recently extended to October 30.
To learn more about AHLA and the educational resources available to the health law community, visit americanhealthlaw.org.
David Cade, AHLA CEO, speaks to Brenna Jenny, Deputy General Counsel and CMS Chief Legal Officer, U.S. Department of Health and Human Services, about Executive Order No. 13891. They discuss what the order requires, what’s in HHS’ proposed rule implementing the order, and how the rule would affect HHS operations. The podcast also covers what sort of input the agency is seeking from stakeholders in response to its RFI issued last month. The comment deadline for the RFI was recently extended to October 30.
To learn more about AHLA and the educational resources available to the health law community, visit americanhealthlaw.org.
I am David Cade, c e o of the American Health Law Association, Brenna. Jenny joins us today to talk about promoting the rule of law through improved agency guidance documents. An executive order number 13,891, signed by the president on October 9th, 2019, and most specifically, the Department of Health and Human Services good guidance practices, notice of proposed rulemaking published on August 20th, 2020. Brenna currently serves as a Deputy General Counsel and the Chief Legal Officer for the Centers for Medicare and Medicaid Services. Within the Department of Health and Human Services, Jenna joined HHS from the Department of Justice, where she served as a council in the civil division at hhs. Brenna has been active in the department's regulatory reform initiatives. Brenna, this is a unique opportunity for us and for our listening audience. So thank you for being available for this podcast and for sharing with the health law community why this is an important initiative. Let's start with why the president issued the executive order. What is the administration trying to achieve?
Speaker 2:The executive order addresses a two-part problem. First, federal agencies have sometimes imposed binding obligations through guidance rather than going through rule making under the guise of merely providing a new interpretation of an existing statute or regulation. This EO reiterates that under the exec, uh, administrative Procedure Act, this is not permissible. Second, even when an agency does issue guidance that is appropriate in that it does not impose new obligations on regulated parties. The massive size of the current administrative state can make it difficult for regulated entities to get their arms around and understand all of the guidance applicable to them. It can feel like there are a series of unwritten rules and companies have to hire expensive beltway lawyers to tell them what those unwritten rules are. So an important part of this EO is creating an operational solution to this problem.
Speaker 1:That's great. And then, and in August, HHS issued a proposed rule relating to good guidance practices. I understand that the comment period closed a few weeks ago. Can you tell us more about this notice of proposed rulemaking?
Speaker 2:The mprm implemented executive order 13 8 91, but the M wasn't just about implementing that eo rather it's just one component of the department's broader regulatory reform initiative. The proposed rule is designed to increase accountability, improve the fairness of guidance issued by the Department Guard against unlawful regulation through guidance and safeguard the important principles underlying the United States Administrative Law System. And I'd like to thank everyone who submitted comments. We received almost 90 comments, including from many of the major trade associations across the healthcare sector. So we were very happy to see such robust public participation.
Speaker 1:I'm glad that public responded so well and I know that the agency will in fact read them and factor those comments in, uh, before they issue the, the final rule. And, and here again I understand that there are three primary requirements. First, can you tell us about the rules h h s proposed for issuing and using guidance documents including how a guidance document is defined?
Speaker 2:The MPRM defines a guidance document as an agency statement of general applicability intended to have future effect on the behavior of regulated parties. And that sets forth a policy on a statutory regulatory or technical issue or an interpretation of a statute or regulation. Now this sounds pretty formalistic, but as we stated in the nprm, ultimately we apply a functional test when identifying guidance. The focal point of the analysis is whether a document is designed to shape the behavior of regulated parties. Now, in terms of requirements on issuance and use of guidance, first and foremost, the MPRM reiterates a preexisting requirement from the Administrative Procedure Act that guidance documents cannot impose binding new obligations unless authorized by law. The MPRM also proposes a boiler plate disclaimer that would need to be included on all guidance documents issued after the rule is finalized. The disclaimer would state as follows. The contents of this document do not have the force and effective law and on are not meant to bind the public in any way unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. All guidance issued after the rule is finalized would need to include certain specified pieces of information, including a unique agency identifier and citations to relevant statutes and regulations. The NPRM also proposes heightened procedures for issuing what are called significant guidance documents, such as a guidance document that could have at least a hundred million annual effect on the economy. We expect significant guidance documents to be quite rare.
Speaker 1:I wanna turn to the second, uh, requirement and that is that the NPR M would require HHS to establish a single searchable guidance website. That seems like a huge task. How does the website intersect with the rule?
Speaker 2:It has been quite an undertaking. Uh, and HHS has actually already, um, started to stand up this guidance repository. You can find it at hhs.gov/guidance. And the rule is finalized would require HHS to continue to maintain the website. We've been hard at work for months, um, posting guidance documents to that website. And under the proposed rule, all of HH S'S existing guidance must be posted to the repository by mid-November. And if it's not posted, it will be considered rescinded. Um, now that date of mid-November is subject to change depending on when the rule is finalized. If a guidance document becomes rescinded because it's not posted, HHS would need to reissue the guidance document by following the rules applicable to newly issued guidance.
Speaker 1:And for those who are keeping track and wanna take a deeper dive, it's hhs.gov/guidance. The last, the third, um, requirement is that the NPRM proposes a petition process. What would stakeholders need to do to use that process?
Speaker 2:The NPRM proposes a process by which interested parties can petition HHS and ask the department to modify or rescind a guidance document, for example, because the guidance document is unlawful or it's being used unlawfully, we expect that petitions will generally raise questions of law and therefore the office of the general counsel will be heavily involved in petition responses. We will be posting more information on our guidance website in the future about how regulated parties can submit petitions to hhs.
Speaker 1:Great. Thank you on for that. I, uh, in taking a look at the nprm, you know, you make clear that F FDA is not part of the proposed rule. Why
Speaker 2:F FDA currently operates under a set of good guidance practices, regulations, and it has for some time, it's, uh, actually a requirement in the Federal Food Drug and Cosmetic Act. So in the nprm we explain that FDA would be amending its good guidance practices, regulations to be consistent with the guidance document requirements imposed on the rest of the department. So no component of HHS is getting a pass in any way. All of HHS will be held to the same standard.
Speaker 1:And it kind of sounds like, um, HHS already has a step forward based on FDA's past practices. So this is not so new, it seems to me. I wanna check in a little bit on your forecasting. If the final rule, if the rule is finalized, actually, how do you think it will affect the department's operations?
Speaker 2:Internally, we will have more structure around how we release guidance documents. Some of that structure will involve coordinating with O M B, the Office of Management and Budget, because O M B would make the final determination as to whether a guidance document qualifies as significant. So our guidance development process will need to build in some time for potential O M B review, but ultimately I think this rule will significantly enhance the department's operations when it comes to issuing guidance documents. For example, for guidance documents issued after the final rule, we proposed that if a guidance document replaces or revises a previously issued guidance document, that HHS must identify that previously issued guidance document that is being revised or replaced. So this sort of process, while it certainly imposes some time burdens on the department, it will also help us avoid having to rely on institutional memory as the department modifies its interpretive statements over time,
Speaker 1:The former Fed. And it's such a treat to talk to you Brenna, the current Fed. Um, the word that comes to my mind is efficiency, uh, you know, following your, your description and, and I think everybody would enjoy the fact that we are at the end of the day becoming more efficient in what we do. Um, another couple of questions, uh, on this topic. HHS issued a request for information about guidance documents. Comments were originally due on October 12th, however, HHS recently announced an extension to the end of the month, October 30th. What kind of information is the department seeking with this rfi?
Speaker 2:In the rfi, we noted that as HHS works to implement executive order 13 8 91, the department is broadly seeking input from regulated parties and other interested parties about specific guidance documents that should in light of their content, current use or agency practice, actually be issued through notice and comment rulemaking. We ask that providers give us a copy of the guidance document or documents at issue and we suggested that they provide a brief summary of their concerns. The purpose of the RFI is to enlist the industry to help us identify where guidance documents are not complying with existing legal obligations. Although our good guidance practices nprm contributed to our interest in issuing the rfi, the RFI is ultimately focused on compliance with existing legal obligations, particularly the Administrative Procedure Act. We've received some comments already and HHS is really looking forward for even more feedback from interested parties and I very much hope that some listeners will respond to the rfi.
Speaker 1:I know that the RFI does not stand alone. I understand that this notice and ultimate regulation is part of the department's broader regulatory reform initiative. So Brenna, can you tell us how this part factors into the broader initiative and what successful adoption of this regulatory initiative will mean for regulated parties like healthcare providers?
Speaker 2:Deputy Secretary, secretary Hargan, who leads our regulatory sprint to coordinated care has been at the forefront of a lot of the department's regulatory reform work, including this mprm, as he has explained, regulatory reform is an opportunity to examine the barriers that regulations create between market actors and to determine how we can reshape those barriers or reduce them so that new solutions can emerge. Much of the department's regulatory reform work, like our efforts to propose reforms to the Stark Law and the anti kickback statute have been about reshaping regulations that may create barriers. I view the good guidance practices, NPRM and the RFI that I discussed as a more foundational component of the department's broader regulatory reform work. We looked holistically at our process for issuing guidance and said, how can we make sure that the way we interpret our regulations and communicate those interpretations to outside parties does not create barriers for market actors and healthcare providers? This rule is finalized would create a process for issuing guidance that will, we hope, make it easier for regulated parties to access and understand the department's interpretations of binding obligations.
Speaker 1:So for that, I have two words. I talked about efficiency as one of my takeaways. Predictability and transparency are the other two takeaways that I see and I offer that as for consideration to the listening audience. Um, I would remind the listening audience, I think this is right Brenda. There's two weeks left for comments to come in on the rfi. So I urge folks who are listening to this to work, uh, with their clients and colleagues to make sure they take the time to respond. Um, I know, and I guess I would, I would share that HHS does read them. So folks out there, the listening audience, think that the comments just go into a black hole. They do not. People like Brenna, you read them and they will be under consideration. In closing out, I just wanna remind folks that Brenna Jenny is the Deputy General Counsel and the Chief Legal Officer for the Centers for Medicare and Medicaid Services within the Department of Health and Human Services. Um, it's a pleasure to have you join us today, Brenna and I want to thank the listening audience for listening to today's podcast. Thank you.
Speaker 2:Thanks for having me, David.