Health and Human Services Department — The Department of Health and Human Services, Administration for Children and Families proposes to further amend the Native American Programs Act regulations to streamline the part. (29 days remaining)
Health and Human Services Department — The Food and Drug Administration (FDA, we, or the Agency) is announcing the availability of a draft guidance for industry titled "Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants." The draft guidance states that, at this time and based on our current understanding of the risks, FDA does not intend to enforce certain regulatory requirements as they apply to certain entities and/or activities. The applicable requirements are established in our regulation titled "Requirements for Additional Traceability Records for Certain Foods." (45 days remaining)
Health and Human Services Department — This proposed rule would amend the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to allow for virtual access under the CLIA certificate of the primary testing laboratory that generated the data, with the exception of the subspecialty of cytology, and the use of digital images for gynecologic cytology proficiency testing. This proposed rule also includes proposed changes to personnel qualification requirements and other proposed changes pertaining to SARS-CoV-2 reporting requirements, certificate requirements, test reporting requirements, enforcement requirements, public consultation requirements, and editorial and technical updates. These proposed updates aim to strengthen the Federal oversight of clinical laboratories and ensure accurate and reliable patient test results while adapting to modern technological capabilities and industry needs, including workforce shortages. (55 days remaining)
Health and Human Services Department — This request for information (RFI) solicits technical input on the services and business practices of pharmacy benefit managers ("PBMs") and their affiliates to inform implementation of recent legislation. It specifically focuses on gathering information to inform two specific legislative requirements that are effective beginning calendar year 2028: restrictions on the remuneration that PBMs and their affiliates may receive for services in connection with the utilization of covered Part D drugs; and data reporting requirements. (32 days remaining)
Health and Human Services Department — This proposed rule would codify the Medicare Drug Price Negotiation Program ("Negotiation Program") and would establish certain new policies for the Negotiation Program and the Medicare Prescription Drug Benefit Program as required by the Inflation Reduction Act of 2022. This proposed rule would also propose a modification to the fixed combination drug policy. (62 days remaining)
Health and Human Services Department — In this notice of proposed rulemaking (NPRM), the Administration for Children and Families (ACF) proposes to remove requirements from the Head Start Program Performance Standards (Performance Standards) to restore local flexibility to Head Start programs and improve access to quality services. Specifically, this NPRM proposes to remove requirements related to wages and benefits that the Administration believes are not in line with the plain language of the Head Start Act and are costly and overly prescriptive for Head Start programs and staff. ACF estimates these proposed changes, if finalized, will result in over $2 billion in future cost savings for Head Start programs. The proposed rescissions in this NPRM, if finalized, would impact the costliest parts of the final rule published by the Office of Head Start (OHS) in 2024, Supporting the Head Start Workforce and Consistent Quality Programming.\1\ --------------------------------------------------------------------------- (29 days remaining)
Health and Human Services Department — These proposals are intended to improve the electronic exchange of health care data and streamline processes related to prior authorization by increasing the interoperability of systems used across the health care industry. We are proposing new requirements for Medicare Advantage (MA) organizations, state Medicaid fee-for-service (FFS) programs, state Children's Health Insurance Program (CHIP) FFS programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plan (QHP) issuers on the Federally-facilitated Exchanges (FFEs), including issuers that offer small group market QHPs on the Federally-facilitated Small Business Health Options Program (FF- SHOP) Exchanges (hereinafter referred to as "small group market QHP issuers on the FF-SHOPs") (collectively "impacted payers"), to make available electronic prior authorization for drugs. We are also proposing to extend many existing interoperability requirements for the prior authorization of non-drug items and services to include prior authorizations for drugs to further reduce patient and provider burden. We are also proposing to require impacted payers to report their application programming interfaces (API) endpoints and related information for the Patient Access, Provider Directory, Provider Access, Payer-to-Payer, and Prior Authorization APIs to CMS. To help assess the impact of our policies, we are proposing to collect API usage metrics. In addition, we are proposing to apply the existing interoperability requirements to small group market QHP issuers on the FF-SHOPs as impacted payers. To improve impacted payers' ability to exchange health information while continuing CMS's drive toward interoperability, we are proposing to require certain Health Level Seven (HL7[supreg]) Fast Healthcare Interoperability Resources (FHIR[supreg]) implementation guides (IGs) that are currently recommended. In addition, HHS is proposing to adopt the HL7 FHIR base standard and certain associated specifications and IGs as the Health Insurance Portability and Accountability Act of 1996 (hereinafter referred to as "HIPAA") (Pub. L. 104-191, enacted Aug. 21, 1996) standards for dental, professional, and institutional "referral certification and authorization" transactions and "eligibility for a health plan" transactions associated with prior authorization. We are proposing to add a definition for "failure to report," which would allow CMS to impose a civil monetary penalty (CMP) on applicable manufacturers or applicable group purchasing organizations (GPOs) if those entities fail to grant CMS timely access to documents for the purposes of an audit. Finally, ONC is using this rulemaking to propose to adopt updated versions of certain health information technology (health IT) standards and specifications for HHS use, such as CMS's interoperability requirements, to support a more robust health IT infrastructure. (61 days remaining)
Health and Human Services Department — The Department of Health and Human Services, Administration for Children and Families proposes to amend the Block Grants regulations, the Individual Development Account Reserve Funds Established Pursuant to Grants for Assets for Independence regulations, and the Emergency Community Services Homeless Grant Program regulations to eliminate unnecessary or obsolete regulations. The docket on https:/ /www.regulations.gov will include a plain language summary of the NPRM as required. (30 days remaining)
Health and Human Services Department — This rulemaking proposes to update the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPFs), which include psychiatric hospitals and excluded psychiatric units of an acute care hospital or critical access hospital. This rulemaking also proposes refinement of the IPF PPS outlier policy. These changes would be effective for IPF discharges occurring during the fiscal year beginning October 1, 2026, through September 30, 2027. We are also proposing the implementation of a standardized IPF patient assessment instrument, and the removal of two measures used in the Inpatient Psychiatric Facilities Quality Reporting Program. (55 days remaining)
Health and Human Services Department — This rule proposes changes and updates to the policies and payment rates used under the Skilled Nursing Facility (SNF) Prospective Payment System (PPS) for fiscal year 2027. This proposed rule also updates the requirements for the SNF Quality Reporting Program and the SNF Value-Based Purchasing Program. (54 days remaining)
Health and Human Services Department — The Department of Health and Human Services, Administration for Children and Families, proposes to remove duplicative or unnecessary Sections from the Family Violence Prevention and Services program regulations (45 CFR part 1370). These amendments will streamline the Family Violence Prevention and Services regulations and make them more accessible to the public. The docket on https:// www.regulations.gov will include a plain language summary of the NPRM. (30 days remaining)
Health and Human Services Department — This proposed rule would update the hospice wage index, payment rates, and aggregate cap amount for Fiscal Year (FY) 2027. This proposed rule also includes an analysis of Medicare non-hospice spending, including details regarding a hospice service and spending variation index (SSVI), and proposes to require that hospices provide the hospice election statement addendum to all Medicare beneficiaries at the time of hospice election. Additionally, this rule proposes conforming regulation text changes to discharge from hospice care regulations; regulation text changes to the face-to-face encounter regulations; and includes requests for information on community palliative care services; the construction of a hospice specific wage index; and the overlap between hospice and medical aid in dying (MAID). Finally, this rule proposes changes to the Hospice Quality Reporting Program. (55 days remaining)
Health and Human Services Department — The Department of Health and Human Services, Administration for Children and Families proposes to remove duplicative or unnecessary sections from the Runaway and Homeless Youth Program regulations (45 CFR part 1351). These amendments will streamline the Runaway and Homeless Youth Program regulations to make them more accessible to the public. The docket on https://www.regulations.gov will include a plain language summary of the NPRM. (30 days remaining)
Health and Human Services Department — ACF proposes to make changes to the Temporary Assistance for Needy Families (TANF) program regulations to reset the base year of the caseload reduction credit from fiscal year (FY) 2005 to the new year established by Congress, which is currently FY 2015, and to exclude from the TANF work participation rate calculations certain cases that receive assistance payments benefits of less than $35 for a month. These changes are required by the Fiscal Responsibility Act (FRA) of 2023. The docket on https://www.regulations.gov will include a plain language summary of the NPRM as required by 5 U.S.C. 553(b)(4). (28 days remaining)
Health and Human Services Department — This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2027. As required by statute, this proposed rule includes the classification and weighting factors for the IRF prospective payment system's case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2027. It also continues the third year of the 3-year phaseout of the rural adjustment, which began in FY 2025. This proposed rule includes a solicitation for public comments on alternative data sources for the IRF PPS wage index; proposes to require all therapy treatments or therapy evaluations to begin within 36-hours from midnight on the day of admission; proposes to require a patient's current functional status be documented on the preadmission screening; proposes requirements for the initial Interdisciplinary Team meeting; and includes a request for information on potential future IRF PPS payment reform. Additionally, the proposed rule includes updates to the IRF Quality Reporting Program. Furthermore, the proposed rule includes changes to the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Competitive Bidding Program. (55 days remaining)