';
Tags Posts tagged with "Notice of Proposed Rulemaking"

Notice of Proposed Rulemaking

Earlier this month the Drug Enforcement Agency (DEA) issued a Notice of Proposed Rulemaking (NPRM) for Special Registrations for Telemedicine and Limited State Telemedicine Registrations. DEA is seeking public comment by March 18, 2025.

RCPA is considering whether it will submit comments. If you have comments about the proposed rule that you would like to make part of any RCPA response or if you would like to discuss the proposed rule, please contact RCPA SUD Treatment Services Policy Director Jason Snyder.

The NPRM introduces three types of Special Registrations for Telemedicine:

  1. A Telemedicine Prescribing Registration, authorizing qualified clinician practitioners to prescribe Schedule III-V controlled substances via telemedicine;
  2. An Advanced Telemedicine Prescribing Registration, authorizing qualified, specialized clinician practitioners (i.e., psychiatrists, hospice care physicians, physicians rendering treatment at long-term care facilities, and pediatricians for the prescribing of medications identified as the most addictive and prone to diversion to the illegal drug market) to prescribe Schedule II-V controlled substances via telemedicine; and
  3. A Telemedicine Platform Registration, authorizing covered online telemedicine platforms, in their capacity as platform practitioners, to dispense Schedule II-V controlled substances. To satisfy the statutory requirements, DEA would also require the special registrant to maintain a State Telemedicine Registration for every state in which a patient is treated by the special registrant, unless otherwise exempted. The State Telemedicine Registration would be issued by DEA, not the states, and operate as an ancillary credential, contingent on the Special Registration held by the special registrant.

Public comments are also requested on additional patient protections for the prescribing of Schedule II medications by telemedicine, including:

  • Whether the special registrant should be physically located in the same state as the patient being prescribed Schedule II medications;
  • Whether to limit Schedule II medications by telemedicine to medical practitioners whose practice is limited to less than 50 percent of prescriptions by telemedicine; and
  • The appropriate duration needed for the rules’ provisions to be enacted.

The special registration rule will also require the establishment of a national prescription drug monitoring program (PDMP) to help the health industry protect against abuse and the diversion of controlled substances into the illegal drug market. A national PDMP will provide pharmacists and medical practitioners with visibility of a patient’s prescribed medication history.

The Centers for Medicare and Medicaid Services (CMS) released two notices of proposed rulemaking (NPRM): Ensuring Access to Medicaid Services and Managed Care Access, Finance, and Quality.

If adopted as proposed, the rules would establish national standards for access to care regardless of whether that care is provided through managed care plans or directly by states through fee-for-service (FFS). Specifically, they would establish access standards through Medicaid or CHIP managed care plans, as well as transparency for Medicaid payment rates to providers, including hourly rates and compensation for certain home care and other direct care workers. The rules would also establish other access standards for transparency and accountability and empower beneficiary choice.

The proposed rules together include new and updated proposed requirements for states and managed care plans that would establish tangible, consistent access standards and a consistent way to transparently review and assess Medicaid payment rates across states. The rule also proposes standards to allow enrollees to easily compare plans based on quality and access to providers through the state’s website.

Other highlights from the proposed rules include:

  • Establishing national maximum standards for certain appointment wait times for Medicaid or CHIP managed care enrollees, and stronger state monitoring and reporting requirements related to access and network adequacy for Medicaid or CHIP managed care plans, which now cover the majority of Medicaid or CHIP beneficiaries;
  • Requiring states to conduct independent secret shopper surveys of Medicaid or CHIP managed care plans to verify compliance with appointment wait time standards and to identify where provider directories are inaccurate;
  • Creating new payment transparency requirements for states by requiring disclosure of provider payment rates in both fee-for-service and managed care, with the goal of greater insight into how Medicaid payment levels affect access to care;
  • Establishing additional transparency and interested party engagement requirements for setting Medicaid payment rates for home and community-based services (HCBS), as well as a requirement that at least 80 percent of Medicaid payments for personal care, homemaker, and home health aide services be spent on compensation for direct care workers (as opposed to administrative overhead or profit);
  • Creating timeliness-of-access measures for HCBS and strengthening necessary safeguards to ensure beneficiary health and welfare as well as promote health equity;
  • Strengthening how states use state Medical Care Advisory Committees, through which stakeholders provide guidance to state Medicaid agencies about health and medical care services, to ensure all states are using these committees optimally to realize a more effective and efficient Medicaid program that is informed by the experiences of Medicaid beneficiaries, their caretakers, and other interested parties;
  • Requiring states to conduct enrollee experience surveys in Medicaid managed care annually for each managed care plan to gather input directly from enrollees; and
  • Establishing a framework for states to implement a Medicaid or CHIP quality rating system, a “one-stop-shop” for enrollees to compare Medicaid or CHIP managed care plans based on quality of care, access to providers, covered benefits and drugs, cost, and other plan performance indicators.

The proposed rules will be published in the May 5, 2023, Federal Register, and comments will be accepted through July 3, 2023.