Rules, rules, rules: Biden administration releases unified agenda for spring 2024

We are in the midst of a storm of regulations being published by the Centers for Medicare & Medicaid Services (CMS) and the U.S. Department of Health and Human Services (HHS), including the proposed regulation on the physician fee schedule for calendar year (CY) 2025; the proposed regulation on the outpatient flat-rate payment system for calendar year 2025; and the proposed regulation on health data, technology, and interoperability: patient engagement, information sharing, and interoperability in public health. Don’t worry, we’ll cover these issues in more Regs & Eggs posts soon!

In the meantime, as we delve into these major regulations, I thought it would be important to touch on the Biden administration’s plan for future regulations. Late Friday evening (July 5, 2024), the administration released its Spring 2024 Consolidated Agenda (a few months late) that lists all the regulations the administration plans to issue by the end of the year and next.

Some of this legislation is expected. For example, all of the Medicare payment regulations (for doctors, hospitals, facilities, and Medicare Advantage and Medicare prescription drug plans) are listed here. These regulations are rotated out every year, and people in the health policy community know when they will be released (though, as we recently witnessed, not exactly when).

However, there are also some new regulations that were not included in the previous uniform agenda, as well as others that we knew about earlier but expected to be published relatively soon and which have now been delayed.

The tables below set out some of the key regulations covered by the Single Plan (excluding regulations on payments) and their expected dates of issue, as well as some comments.

Provisions of the No Surprises Act

Observations

It’s no surprise (pun intended) that implementation of the No Surprises Act remains difficult. The first three regulations listed were supposed to be fully implemented by 2022. They include important patient protections, such as the Advanced Explanation of Benefits, which will allow patients with insurance to better understand the costs of planned services before they receive them.

The November 2024 issuance date of the Independent Dispute Resolution (IDR) Operations Final Rule (CMS-9897) is also of concern to many stakeholders. This regulation makes important changes to the federal IDR process that are intended to streamline the process. We initially anticipated that these reforms would take effect late this year. However, given the year-end issuance date for the regulation, it is unlikely that these rules will take effect before early or mid-2025 (the proposed effective dates for the rules are several months after the issuance of the final rule).

Other HHS regulations

Observations

Not surprisingly, HHS seems to have a long list of regulations it wants to release in the future (in addition to the annual payment regulations) since these are the last six months of President Biden’s first term (or the Biden administration, depending on what happens in November). These regulations represent key administration health care priorities, such as streamlining the organ procurement process and addressing mental health parity.

Three bolded regulations are of particular interest. In the proposed rule on interoperability standards and prior authorization for prescription drugs (CMS-0062), CMS is signaling that the agency is not finished implementing new prior authorization requirements and plans to create new standards for the use of prior authorization for prescription drugs. CMS also plans to issue a final rule soon that would provide interim coverage for emerging technologies through the NCD process. Finally, and notably, CMS plans to issue a proposed rule in December 2024 that would amend HIPAA to improve cybersecurity in the healthcare sector. This could be one of the first major healthcare regulations to address the growing problem of cyberattacks.

U.S. Department of Justice (DOJ)/Drug Enforcement Administration (DEA) Regulations

Observations

The DEA is notorious for being slow to issue health care regulations (since it is a law enforcement agency, not a health care agency). The agency has a number of important health care regulations it has been working on… for some time!

For example, we have been waiting for the final regulation on electronic prescribing for controlled substances to be released. The Fall 2023 Consolidated Agenda listed the release date as November 2023 – and now it is December 2024. The EMS regulation (1117-AB37), which would have authorized the dispensing of controlled substances via “standing orders,” has been long delayed. The proposed regulation was released in 2020 (three years after the law authorizing standing orders was passed). The last Consolidated Agenda listed the release date as December 2023 – and now it is December 2024. This one-year delay between the projected release dates in that Consolidated Agenda and those in the last Consolidated Agenda also applies to many of the other DEA healthcare regulations listed above.

Finally, many stakeholders are interested in when the telemedicine prescribing regulations will be released. The Special Registrations for Telemedicine and Limited State Telemedicine Registrations and the Expansion of Induction of Buprenorphine via Telemedicine Encounter regulations are both scheduled to be released in September 2024 – but based on DEA’s established history, these dates are not set in stone!

Occupational Safety and Health Administration (OSHA) Workplace Violence Regulation

Observations

This regulation would establish standards for workplace violence in health care settings. Like the DEA process, OSHA’s rulemaking process is slow. As noted, OSHA began the rulemaking process in 2016 and most recently convened a Small Business Advocacy Review Panel in March 2023 and issued a report on May 1, 2023. There have been no significant changes to the regulation since then. While OSHA has other priorities, workplace violence is a serious problem that can lead to provider burnout and raise serious patient safety concerns.

Well, that’s a look at some of the major regulations in the Spring 2024 United Agenda! And that may not be all the regulations we’ll see! For example, the U.S. Department of Veterans Affairs plans to release proposed regulations and RFIs for new standards of practice for various healthcare professionals. We know the Department plans to release some of these in the future (since they’ve released a few so far), but the regulations are nowhere to be found in the United Agenda!

Stay tuned as we’ll be releasing a big roundup of regulations and tidbits soon, where we’ll be covering the most important CMS and HHS regulations that have already been released!

See you next week, Jeffrey says, enjoy reading the egg recipes.

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