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July 11, 2024 – 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.
| Regulation | Description in Unified Agenda | Estimated Release Date |
| HHS/CMS: Provider Nondiscrimination Requirements for Group Health Plans and Health Insurance Issuers in the Group and Individual Markets (CMS-9910); Proposed Rule Stage; Regulatory number: 0938-AU64 | This proposed rule would implement section 108 of the No Surprises Act (NSA). This provision requires that HHS and the US Departments of Labor and the Treasury issue regs no later than January 1, 2022, to implement changes made by the Affordable Care Act (ACA) to the Public Health Service (PHS) Act protections against provider discrimination. | August 2024 |
| HHS/CMS: Requirements Related to Advanced Explanation of Benefits and Other Provisions Under the Consolidated Appropriations Act 2021 (CMS-9900); Proposed Rule Stage; Regulatory number: 0938-AU98 | This proposed rule would implement section 9816 of the Internal Revenue Code of 1986, section 716 of the Employee Retirement Income Security Act of 1974 (ERISA) and section 2799A1 of the PHS Act, as directed by section 111 of the NSA, and may include other provisions under the Consolidated Appropriations Act, 2021. | March 2025 |
| HHS/CMS: Requirements Related to Air Ambulance Services, Agent and Broker Disclosures, and Provider Enforcement (CMS-9907); Final Rule Stage; Regulatory number: 0938-AU61 | This rule provides the form and manner in which group health plans, health insurance issuers offering group or individual health insurance coverage, and providers of air ambulance services would report information regarding air ambulance services. | March 2025 |
| HHS/CMS: Independent Dispute Resolution Operations (CMS-9897); Final Rule Stage; Regulatory number: 0938-AV15 | This final rule amends the Requirements Related to Surprise Billing; Part I (July 2021 interim final rules), Requirements Related to Surprise Billing Interim Final Rules; Part II (October 2021 interim final rules), and Requirements Related to Surprise Billing Final Rules (August 2022 final rules), which set forth requirements related to Title I (NSA) and Title II (Transparency) of Division BB of the Consolidated Appropriations Act, 2021. | November 2024 |
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).
| Regulation | Description | Estimated Release Date |
| HHS/OIG: Medicare and State Health Care Programs: Fraud and Abuse; Establishment of New Safe Harbors Under the Federal Anti-Kickback Statute; Proposed Rule Stage; Regulatory number: 0936-AA13 | The proposed rule would (1) propose a safe harbor to implement a statutory exception, enacted through the Consolidated Appropriations Act of 2023, to protect certain bona fide mental health and behavioral health improvement or maintenance programs provided by hospitals, ambulatory surgical centers, community health centers, rural emergency hospitals, skilled nursing facilities or similar entities, as determined by the Secretary, to physicians or other clinicians; and (2) propose a safe harbor to protect certain evidence-based contingency management programs for the treatment of substance use disorders. | November 2024 |
| HHS/OASH: Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity Act; Proposed Rule Stage; Regulatory number: 0937-AA13 | This proposed rule would amend 42 CFR 121.6 to remove clinical research and institutional review board requirements for kidney and liver transplants of organs from people with human immunodeficiency virus (HIV). The proposed rule would continue to require that the Organ Procurement and Transplantation Network adopt and use standards of quality with respect to kidneys and livers donated by persons with HIV, consistent with the National Organ Transplant Act of 1984, and in a way that ensures the use of kidneys and livers from people with HIV will not reduce the safety of organ transplantation. | October 2024 |
| HHS/CMS: Amendments to Rules Governing Organ Procurement Organizations (CMS-3409); Proposed Rule Stage; Regulatory number: 0938-AU54 | This rule follows the December 3, 2021, transplant system modernization request for information and proposes clarifications and technical modifications to the standards used to evaluate and recertify organ procurement organizations (OPOs) and to the competition and decertification process for organ procurement organizations. Revisions would continue to hold OPOs responsible for improved performance. | March 2025 |
| HHS/CMS: Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers II; Proposed Rule Stage; Regulatory number: 0938-AV21 | This proposed rule would revise and update national emergency preparedness requirements for Medicare and Medicaid participating providers and suppliers to plan adequately for both natural and human-made disasters, including climate-related disasters, and to coordinate with federal, state, tribal, regional and local emergency preparedness systems based on lessons learned during the COVID-19 public health emergency and other recent events. | July 2024 |
| HHS/CMS: Administrative Simplification: Modifications to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Electronic Transaction Standards Version 8020 (CMS-0061); Proposed Rule Stage; Regulatory number: 0938-AV43 | This proposed rule seeks to adopt the updated versions of the standards for the electronic exchange of health information under the Administrative Simplification subtitle of HIPAA. This rule would propose to replace the X12 Technical Reports Type 3, Version 5010 with the X12 Technical Reports Type 3, Version 8020 for healthcare claims or equivalent encounter information transactions (Institutional, Professional and Dental) and electronic remittance advice transactions. These updated versions of the X12 standards would promote interoperability and ease the administrative burden on providers and health plans. | December 2024 |
| HHS/CMS: Interoperability Standards and Prior Authorization for Drugs (CMS-0062); Proposed Rule Stage; Regulatory number: 0938-AV44 | CMS would propose new requirements for Medicare Advantage (MA) organizations and qualified health plans offered on the federally facilitated exchanges to streamline processes for the prior authorization for certain drugs. CMS is developing this rule, in part, based on the significant number of public commenters who responded to the CMS Interoperability and Prior Authorization proposed rule (87 FR 76238) urging CMS to expand the proposed prior authorization policies to include drugs. | November 2024 |
| HHS/CMS: Administrative Simplification: Adoption of Standards for Health Care Attachment Transactions and Electronic Signatures (CMS-0053); Final Rule Stage; Regulatory number: 0938-AT38 | This rule finalizes new standards for health plans and providers to support both healthcare claims transactions and standards for electronic signatures to be used in conjunction with healthcare attachments transactions. Additionally, this rule finalizes a regulatory change that implements requirements of the Administrative Simplification subtitle of HIPAA and the Patient Protection and Affordable Care Act (Pub. L. 111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152), enacted on March 30, 2010. | November 2024 |
| HHS/CMS: Administrative Simplification: Modifications to NCPDP Retail Pharmacy Standards (CMS-0056); Final Rule Stage; Regulatory number: 0938-AU19 | This final rule requires pharmacies and vendors to modify the currently adopted National Council for Prescription Drug Programs (NCPDP) standards to the Telecommunications Standard Implementation Guide version F6; Batch Standard Implementation Guide version 15; and Batch Standard Subrogation Implementation Guide version 10. | September 2024 |
| HHS/CMS: Transitional Coverage for Emerging Technologies; Response to Comments (CMS-3421); Final Rule Stage; Regulatory number: 0938-AU86 | This final notice responds to public comments received on the June 27, 2023, notice with comment. The notice provided information to the public on the process CMS will use to provide transitional coverage for emerging technologies through the national coverage determination (NCD) process under the Social Security Act. This notice does not alter or amend the regulations that establish rules related to the administrative review of NCDs. | July 2024 |
| HHS/CMS: Mental Health Parity and Addiction Equity Act and the Consolidated Appropriations Act, 2021 (CMS-9902); Final Rule Stage; Regulatory number: 0938-AU93 | This rule would finalize proposed amendments to the final rules implementing the Mental Health Parity and Addiction Equity Act (MHPAEA). The amendments clarify plans’ and issuers’ obligations under the law, promote compliance with MHPAEA and update requirements taking into account experience with MHPAEA in the years since the rules were finalized. The rule would also finalize new regulations implementing amendments to MHPAEA recently enacted as part of the Consolidated Appropriations Act, 2021. | July 2024 |
| HHS/CMS: Coverage of Certain Preventive Services Under the Affordable Care Act (CMS-9903); Final Rule Stage; Regulatory number: 0938-AU94 | This rule would finalize proposed amendments to the final rules regarding religious and moral exemptions and accommodations regarding coverage of certain preventive services under title I of the Patient Protection and Affordable Care Act. | December 2024 |
| HHS/OCR: Proposed Modifications to the HIPAA Security Rule to Strengthen the Cybersecurity of Electronic Protected Health Information; Proposed Rule Stage; Regulatory number: 0945-AA22 | This rule will propose modifications to the Security Standards for the Protection of Electronic Protected Health Information under HIPAA and the Health Information Technology for Economic and Clinical Health Act of 2009. These modifications will improve cybersecurity in the healthcare sector by strengthening requirements for HIPAA regulated entities to safeguard electronic protected health information to prevent, detect, contain, mitigate and recover from cybersecurity threats. | December 2024 |
| HHS/OCR: Rulemaking on Nondiscrimination on the Basis of Disability in Programs and Activities Conducted by HHS; Proposed Rule Stage; Regulatory number: 0945-AA23 | This proposed rule would revise regulations under section 504 of the Rehabilitation Act of 1973 to address discrimination on the basis of disability in programs and activities conducted by HHS. Covered topics may include nondiscrimination in medical treatment, accessible medical equipment, accessible communications, compliance procedures, coordination responsibilities and other disability discrimination issues. | June 2025 |
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.
| Regulation | Description in Unified Agenda | Estimated Release Date |
| DOJ/DEA: Special Registrations for Telemedicine and Limited State Telemedicine Registrations: Proposed Rule Stage; Regulatory number: 1117-AB40 | The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (Pub. L. 110-425) was enacted on October 15, 2008, and amended the Controlled Substances Act by adding various provisions to prevent the illegal distribution and dispensing of controlled substances by means of the internet. The act required an in-person medical evaluation as a prerequisite to prescribing or otherwise dispensing controlled substances by means of the internet, except in the case of practitioners engaged in the practice of telemedicine. The definition of the “practice of telemedicine” includes seven distinct categories that involve circumstances in which the prescribing practitioner might be unable to satisfy the act’s in-person medical evaluation requirement yet nonetheless has sufficient medical information to prescribe a controlled substance for a legitimate medical purpose in the usual course of professional practice. One specific category within the act’s definition of the “practice of telemedicine” includes “a practitioner who has obtained from the [DEA Administrator] a special registration under [21 U.S.C. 831(h)].” 21 U.S.C. 802(54)(E). The act also specifies criteria that the DEA must consider when evaluating an application for such a registration. However, the act contemplates that the DEA must issue regulations to effectuate this special registration provision. After publishing an NPRM on March 1, 2023, and in response to the large volume of comments received, DEA published a notice of meeting to invite all interested persons, including medical practitioners, patients, pharmacy professionals, industry members, law enforcement, stakeholders, community leaders and other third parties, to participate in listening sessions held on September 12 and 13, 2023. The additional feedback received will assist DEA in potential rulemaking. | September 2024 |
| DOJ/DEA: Changes to a Prescription; Proposed Rule Stage; Regulatory number: 1117-AB72 | The purpose of this rule is to modify 21 CFR 1306.05(a) to stipulate when pharmacists and/or pharmacist technicians can make changes and/or additions to schedule II-V written controlled substance prescriptions once a prescription has been signed by a DEA registered practitioner. Currently, 21 CFR 1306.05(a) does not state when or if any changes and/or additions can be made to a controlled substance prescription once a prescription has been signed by a DEA registered practitioner. This uncertainty can result in delays for patients receiving prescriptions of controlled substances. | November 2024 |
| DOJ/DEA: Automation of Reports and Consolidated Orders System (ARCOS) Monthly Reporting; Proposed Rule Stage; Regulatory number: 1117-AB85 | The DEA proposes to improve the effectiveness of ARCOS by requiring more frequent reporting for registrants who utilize the system as well as requiring that such reports be submitted electronically via either the ARCOS Online Reporting System or the Electronic Data Interchange System for distributors and manufacturers. | December 2024 |
| DOJ/DEA: Revision of Application for Manufacturing Quota; Proposed Rule Stage; Regulatory number: 1117-AB86 | The DEA proposes to revise existing regulations that manage the quotas for schedule I and II controlled substances and the list I chemicals ephedrine, pseudoephedrine and phenylpropanolamine, to be utilized by DEA-registered manufacturers. This rule is being proposed to restructure DEA’s manufacturing and procurement quota regulations for more clarity and consistency; clarify which use-specific subcategories for quotas should be used for controlled substances that will be sold domestically and controlled substances that will be exported; and revise the applications for individual manufacturing and procurement quota. These revisions would apply to both bulk and dosage-form manufacturers. The changes are necessary to ensure clarity, provide transparency into the manufacturing process, and ensure enough schedule I and II controlled substances and three list I chemicals are available in the United States to meet estimated scientific, medical, lawful export and inventory needs. | December 2024 |
| DOJ/DEA: Electronic Prescriptions for Controlled Substances; Final Rule Stage; Regulatory number: 1117-AA61 | By this final rule, the DEA would finalize its regulations to clarify (1) the criteria by which DEA-registered practitioners may electronically issue controlled substance prescriptions and (2) the criteria by which DEA-registered pharmacies may receive and archive these electronic prescriptions. The finalized rule would contain modifications from the interim final rule previously published. The final regulations would modify the requirements that must be met by any registrant who wishes to dispense controlled substances pursuant to electronic prescriptions, including requirements pertaining to authorized software applications. (The final rule would maintain the discretionary usage of electronic prescriptions found in the interim final rule.) | December 2024 |
| DOJ/DEA: Emergency Medical Services (EMS); Final Rule Stage; Regulatory number: 1117-AB37 | The DEA is modifying the regulations related to the registration requirements of DEA registrants to allow EMS registrants to transport controlled substances for the purpose of dispensing under certain circumstances, and to provide the EMS community with specific requirements for EMS programs handling controlled substances. As a result of these modifications, the DEA would also modify the security, ordering and recordkeeping requirements for registrants who wish to transport controlled substances for the purpose of dispensing. | December 2024 |
| DOJ/DEA: Suspicious Orders of Controlled Substances; Final Rule Stage; Regulatory number: 1117-AB47 | The DEA is revising its regulations related to suspicious orders of controlled substances. The proposed rule defines the term “suspicious order” and specifies the procedures a registrant must follow upon receiving such orders. | April 2025 |
| DOJ/DEA: Implementation of the SUPPORT Act: Dispensing and Administering Controlled Substances for Medication-Assisted Treatment; Final Rule Stage; Regulatory number: 1117-AB55 | This rulemaking will update the DEA’s regulations to implement the provisions of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018 expanding the range of practitioners eligible to prescribe FDA-approved medications for the treatment of opioid use disorder and modifying provisions governing the delivery of a controlled substance by a pharmacy to a practitioner. | April 2025 |
| DOJ/DEA: Expansion of Induction of Buprenorphine via Telemedicine Encounter; Final Rule Stage; Regulatory number: 1117-AB78 | DEA is promulgating regulatory changes that would clarify the rights and obligations for DEA registrants when prescribing buprenorphine to patients with opioid use disorder pursuant to a telemedicine encounter that utilizes audio-only telecommunication systems. | September 2024 |
| DOJ/DEA: Amending Regulations to Conform to the Controlled Substance Ordering System (CSOS) Modernization; Final Rule Stage; Regulatory number: 1117-AB79 | The DEA proposes to amend regulations to conform with the modernization of the CSOS and require that applications and related materials be submitted online. | March 2025 |
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!
| Regulation | Description in Unified Agenda | Estimated Release Date |
| OSHA: Prevention of Workplace Violence in Health Care and Social Assistance; Proposed Rule Stage; Regulatory number: 1218-AD08 | The request for information (RFI) published on December 7, 2016 (81 FR 88147), provides the Occupational Safety and Health Administration’s (OSHA’s) history with the issue of workplace violence in healthcare and social assistance, including a discussion of the guidelines that were initially published in 1996, a 2014 update to the guidelines, and the agency’s use of 5(a)(1) in enforcement cases in healthcare. The RFI solicited information primarily from healthcare employers, workers and other subject matter experts on impacts of violence, prevention strategies and other information that will be useful to the agency. OSHA was petitioned for a standard preventing workplace violence in healthcare by a broad coalition of labor unions, and in a separate petition by the National Nurses United. On January 10, 2017, OSHA granted the petitions. In accordance with the requirements of the Small Business Regulatory Enforcement Fairness Act (SBREFA), OSHA convened a small business advocacy review panel in March 2023. OSHA issued the SBREFA panel report on May 1, 2023 | December 2024 |
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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