Congress and federal agencies often engage in a game, each trying to see what the other is willing to do to achieve a particular policy or outcome. While Congress and federal agencies have unique authorities (legislative versus regulatory), sometimes it is unclear which authority is the most appropriate to use. In those circumstances, when it’s difficult to determine whether a policy can be accomplished through regulations alone or requires a legislative change, the game becomes most intriguing.
Recent activity related to laboratory developed test (LDT) oversight illustrates the tension that can exist between the regulatory and legislative worlds. In this particular case, the best analogy I can come up with is a game of poker. And to help describe this game (the players and the moves), I’m bringing in my colleagues Rachel Stauffer and Deborah Godes.
First, let us clarify that although we are calling this a “game,” we don’t mean to undermine the significance of the issue or minimize some of the more challenging policy questions we face. Some games can be serious, right? (Just ask any sports fan!)
Ok, with that caveat, let’s describe the game. The players are the US Food and Drug Administration (FDA) and the committees of jurisdiction in Congress (both the US House of Representatives and the US Senate) that oversee FDA’s activities. The policy challenge of regulating and overseeing LDTs has become more of an issue in recent years, as technological advances have led to an increase in these types of tests. Congress and the FDA have been watching this industry closely and evaluating their oversight options for a while now, but the most recent round of poker began last year, when Congress introduced the Verifying Accurate, Leading-edge IVCT Development (VALID) Act. Some members of Congress continue to believe that the FDA does not have the authority to regulate LDTs, and therefore Congress has considered various legislation that would make FDA’s authority clear and provide a framework for LDT regulation. The VALID Act is most recent example of such proposed legislation. But although Congress revealed its hand by introducing the VALID Act, the game did not end there. While a compromise was closer at the end of 2022, no final legislative agreement was reached.
Having seen Congress’s hand and with no legislation enacted, the FDA decided to act. Believing that it does in fact have the authority to regulate LTDs, last week the agency proposed to engage in more direct oversight of LDTs. The FDA’s proposed rule would amend the FDA’s regulations to make explicit that in vitro diagnostic (IVD) products would be considered medical devices under the Federal Food, Drug, and Cosmetic Act, including when the IVD’s manufacturer is a laboratory. The FDA would phase out its existing general enforcement discretion approach for most LDTs over four years.
One of the sticking points in the VALID negotiations was the impact on academic medical centers. In the proposed reg, the FDA discusses this issue and asks for input from stakeholders. The FDA requests a public health rationale, supporting evidence and other information to help inform the agency’s decision-making on alternative enforcement approaches for some IVDs offered as LDTs.
Public comments on the proposed reg are due on December 2, 2023. If you want more information on LDTs and this proposed reg, McDermottPlus has you covered.
READ OUR +INSIGHT ON THE FDA PROPOSED RULE
So, both Congress and the FDA have shown their cards. Now the questions is, how will the next round play out? Some members of Congress may want to weigh in during the public comment period and request that the FDA make modifications or rescind the reg completely (since some members do not believe that the FDA has the authority to act in the first place). Senator Bill Cassidy (R-LA), ranking member of the Senate Committee on Health, Education, Labor and Pensions, has already publicly questioned FDA’s authority and indicated interest in revisiting legislation. In the House, Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) issued a statement expressing concern with the proposed reg’s approach. The lead Democrats on these committees have remained silent. The lead authors of the VALID Act, Reps. Diana DeGette (D-CO) and Larry Bucshon (R-IN), may see FDA’s proposal as an opportunity to bring stakeholders together once again to try to pass the VALID Act. Other members of Congress may want to wait until the FDA issues a final reg to take action—which could include passing a version of the VALID Act.
As Congress and the FDA continue their game, it’s important to remember that members of the general public aren’t merely spectators. You all are able to influence the game by providing regulatory comments to the FDA or writing letters to Congress. We will keep you updated on how this all plays out (pun intended) and let you know what the final policy outcome is.
This is just one example of a game between Congress and federal agencies that is currently playing out. Another example relates to reforming the prior authorization process used by Medicare Advantage plans. In that game, Congress introduced legislation to streamline and automate the process, although stakeholders agree that the Centers for Medicare & Medicaid Services (CMS) has the authority to do so on its own. However, Congress needs CMS to issue new regulatory requirements in order to lower the Congressional Budget Office score and reduce the expected cost of the legislation. CMS introduced a proposed reg to accomplish this goal but hasn’t issued the final reg yet. Thus, in this game, both Congress and CMS are playing at the same table and working towards a similar policy objective.
In the many different types of games that Congress and federal agencies can play together, our hope is that whatever the outcomes are, the true “winners” are always patients.
Until next week, this is Jeffrey (and Rachel and Deb) saying, enjoy reading regs with your eggs.
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