We are in the midst of a storm of regulations that are being released by the Centers for Medicare & Medicaid Services (CMS) and the US Department of Health and Human Services (HHS), including the Calendar Year (CY) 2025 Physician Fee Schedule Proposed Reg; the CY 2025 Outpatient Prospective Payment System Proposed Reg; and the Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability Proposed Reg. Don’t worry, future Regs & Eggs posts will cover these regs soon!
In the meantime, as we dig into these major regs, I thought it would be important to touch upon the Biden Administration’s plan for regs going forward. Late Friday evening (July 5, 2024), the Administration released its Spring 2024 Unified Agenda (a few months late), which lists all the regs that the Administration plans to issue by the end of the year and beyond.
Some of these regs are expected. For example, all the Medicare payment regs (for physicians, hospitals, different facilities, and Medicare Advantage and Medicare prescription drug plans) are laid out here. These regs are listed every year, and folks in the health policy community know about when they will come out (although, as we have recently witnessed, not exactly when).
However, there are also some new regs listed that were not on the previous unified agenda, and others that we had seen before but expected to be released relatively soon, and which have now been delayed.
The tables below show some of the key regs on the unified agenda (excluding the payment regs) and their expected release dates, as well as some observations.
No Surprises Act Regs
Observations
It is no surprise (pun intended) that the implementation of the No Surprises Act continues to be bumpy. The first three regs 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 have a better understanding of the cost of scheduled services before they receive them.
The Independent Dispute Resolution (IDR) Operations (CMS-9897) Final Reg’s release date of November 2024 is also concerning to many stakeholders. This reg makes important changes to the federal IDR process that are meant to improve the process. We initially anticipated that these reforms would become effective later this year. However, with the release date of the reg now set at the end of the year, it is unlikely that these policies will become effective before early- to mid-2025 (the proposed effective dates of the policies were a few months after the final reg is issued).
Other HHS Regs
Observations
It is not surprising that HHS appears to have a laundry list of regs it wants to publish going forward (in addition to the annual payment regs), as this is the last six months of President Biden’s first term (or the Biden Administration, depending on what happens in November). These regs represent the Administration’s key healthcare priorities, such as improving the organ procurement process and addressing mental health parities.
The three regs that are bolded are of particular interest. With respect to the Interoperability Standards and Prior Authorization for Drugs Proposed Rule (CMS-0062), CMS is signaling that the agency is not done with implementing new prior authorization requirements and plans to create new standards around the use of prior authorization for prescription drugs. CMS is also planning to soon release a final reg that would provide transitional coverage for emerging technologies through the NCD process. Finally, of note, CMS is planning to issue a proposed reg in December 2024 that would make modifications to HIPAA in an attempt to improve cybersecurity in the healthcare sector. This may be one of the first major healthcare-related regs that addresses the growing issue of cybersecurity attacks.
US Department of Justice (DOJ)/US Drug Enforcement Administration (DEA) Regs
Observations
The DEA is known for being slow in issuing healthcare regulations (as they are a law enforcement agency, not a healthcare agency). The agency has many important healthcare regs that it has been working on . . . for a while!
For example, we have been waiting for the Electronic Prescriptions for Controlled Substances final reg to be released. In the Fall 2023 Unified Agenda, the release date of the reg was listed as November 2023 – and now it’s December 2024. The EMS reg (1117-AB37) that would allow controlled substances to be dispensed through “standing orders” has been long delayed. The proposed reg was released back in 2020 (three years after a law was passed allowing for standing orders). In the last unified agenda, the release date was December 2023 – and now its December 2024. This year-long delay between the expected release dates found in this unified agenda and those in the last unified agenda also applies to many other DEA healthcare regs listed above.
Lastly, many stakeholders are interested in when the telehealth prescribing regs will be released. The Special Registrations for Telemedicine and Limited State Telemedicine Registrations reg and the Expansion of Induction of Buprenorphine via Telemedicine Encounter reg are both expected to be issued in September 2024 – but based on the DEA’s established track record, these dates are not set in stone!
Occupational Safety and Health Administration (OSHA) Workplace Violence Reg
Observations
This reg would establish workplace violence standards in healthcare facilities. Like the DEA process, the OSHA rulemaking process is slow. As noted, OSHA started 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 has been no notable movement on the reg since then. While OSHA has other priorities, workplace violence is a significant issue that can lead to provider burnout and cause major patient safety concerns.
Well, that’s an overview of some of the major regs in the Spring 2024 Unified Agenda! And that may not be all the regs we will see! For example, the US Department of Veterans Affairs plans to release proposed regs and RFIs on new standards of practice for different healthcare practitioners. We know that the Department plans to release some going forward (as they have already released a few to date), but the regs are nowhere to be found on the unified agenda!
Stay tuned for large helpings of Regs & Eggs going forward as we dive into the major CMS and HHS regs that have now been released!
Until next week, this is Jeffrey saying, enjoy reading regs with your eggs.
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