Medicaid Final Rules Streamline Processes to Improve Access, 340B Dispute Resolution Established

May 7, 2024

The Centers for Medicare & Medicaid Services (CMS) issued a series of final rules aimed at standardizing several aspects of the Medicaid program. Additionally, the Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) issued the long-awaited 340B Administrative Dispute Resolution final rule. Key points from the four rules are listed below.

Streamlining Enrollment in Medicaid Final Rule

This rule includes a series of provisions to simplify and standardize enrollment and renewal processes, bringing the consumer protections made possible by the Affordable Care Act to all enrollees in Medicaid and the Children's Health Insurance Program (CHIP) program, and making it easier for eligible children and adults to stay covered. Specifically, the rule:

  • Requires states to provide all individuals with at least 15 days to provide any additional information when applying for coverage the first time and 30 days to return documentation when renewing coverage.
  • Prohibits states from conducting renewals more frequently than every 12 months and requiring in-person interviews for older adults and those with disabilities.
  • Eliminates annual and lifetime limits on children’s coverage in CHIP.
  • Ends the practice of locking children out of CHIP coverage if a family is unable to pay premiums.
  • Eliminates waiting periods for CHIP coverage so children can access health care immediately.
  • Improves the transfer of children from Medicaid to CHIP when a family’s income rises.

In comments on the proposed rule, the Association for Clinical Oncology (ASCO) supported streamlining Medicaid and CHIP application processes to minimize barriers to coverage and cancer care, in addition to improving health outcomes, enhancing health equity, and promoting clinical trial enrollment. ASCO asserts that no individual diagnosed with cancer should be without health insurance that guarantees access to high-quality, equitable cancer care, which includes care delivered by a cancer specialist.

Ensuring Access in Medicaid Final Rule

On April 22, 2024, CMS published a final rule, “Medicaid Program; Ensuring Access to Medicaid Services.” The rule seeks to increase transparency in payment rates for Medicaid providers in addition to focusing on home- and community-based services (HCBS). Several highlights from the rule include:

  • It requires states to publish all fee-for-service (FFS) Medicaid fee schedule payment rates on a publicly available and accessible website.
  • It requires states to compare their FFS payment rates for primary care, obstetrical and gynecological care, and outpatient mental health and substance use disorder services to Medicare rates and publish the analysis every two years.
  • It requires states to publish the average hourly rate paid for personal care, as well as for home health aide, homemaker, and habilitation services and to publish the disclosure every two years.
  • It requires states to establish and operate the newly named Medicaid Advisory Committee (MAC) and a Beneficiary Advisory Council (BAC) one year after the rule’s effective date.
  • It requires that at least 80% 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).
  • It requires states to ensure that the person-centered service plan is reviewed and revised, at least every 12 months for at least 90% of individuals continuously enrolled in a state’s HCBS programs.
  • It requires states to report on waiting lists in section 1915(c) waiver programs and on service delivery timeliness for personal care, homemaker, home health aide services, and habilitation services. 

In comments on the proposed version of the rule, ASCO supported CMS’ proposal to make FFS payment rates publicly available and easily accessible; however, ASCO does not support Medicaid provider payments that are less than the Medicare payment for the same service.

For additional information on this rule see the CMS fact sheet on the regulation and timeline for the various effective dates. 

Access in Medicaid Managed Care Final Rule

On April 22, 2024, the Centers for Medicare & Medicaid Services (CMS) published the final rule, “Medicaid and Children’s Health Insurance Program Managed Care Access, Finance, and Quality.” The rule includes technical and administrative processes changes in Medicaid managed care. However, it also addresses payment transparency, medical loss ratios (MLRs), and wait time standards. A few highlights from the rule include:

  • The rule creates new payment transparency measures for states by conducting a managed care provider payment rate analysis for certain services.
  • The rule includes requirements for clinical or quality improvement standards for provider incentive arrangements and for expense allocation reporting. The rule would prohibit administrative costs from being included in reporting quality improvement activities.
  • The rule includes several requirements to measure and improve access to care including establishing maximum appointment wait times, requiring secret shopper and enrollee experience surveys, and developing remedy plans for issues that are identified.

ASCO’s comments to the agency included supporting a payment model that increases Medicaid payment rates to equal those for Medicare, while providing incentives to address meaningful quality metrics specific to patients with cancer. The Association’s comments also urged the agency to address prior authorization within the Medicaid program, which can cause delays to necessary cancer care.

For additional information on this final rule see the CMS fact sheet and chart on effective dates.

340B Administrative Dispute Resolution Final Rule

On April 18, 2024, the Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) issued the long-awaited 340B Administrative Dispute Resolution (ADR) final rule. The rule represents the latest development in establishing the 340B ADR process, which has been delayed for more than a decade. Three key takeaways from this rule are:

  • It explicitly allows 340B covered entities to bring claims against manufacturers that are restricting sales of drugs at the 340B ceiling price.
  • It allows claims similar to those pending in federal court to continue.
  • It allows manufacturers to bring claims against 340B covered entities for alleged duplicate discount violations for drugs purchased for Medicaid managed care enrollees.

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