{"description":"Documents matching 'problems known impact consequence patient'","count":1740,"total_pages":50,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bterm%5D=problems+known+impact+consequence+patient&format=json&page=2","results":[{"title":"Continuity of Care via Telemedicine for Veterans Affairs Patients","type":"Rule","abstract":"This final rule authorizes Department of Veterans Affairs (VA) practitioners acting within the scope of their VA employment to prescribe controlled substances via telemedicine to a VA patient with whom they have not conducted an in-person medical evaluation. VA practitioners are permitted to prescribe controlled substances to VA patients if another VA practitioner has, at any time, previously conducted an in-person medical evaluation of the VA patient, subject to certain conditions.","document_number":"2025-01044","html_url":"https://www.federalregister.gov/documents/2025/01/17/2025-01044/continuity-of-care-via-telemedicine-for-veterans-affairs-patients","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-01-17/pdf/2025-01044.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-01044.pdf?1736948756","publication_date":"2025-01-17","agencies":[{"raw_name":"DEPARTMENT OF JUSTICE","name":"Justice Department","id":268,"url":"https://www.federalregister.gov/agencies/justice-department","json_url":"https://www.federalregister.gov/api/v1/agencies/268","parent_id":null,"slug":"justice-department"},{"raw_name":"Drug Enforcement Administration","name":"Drug Enforcement Administration","id":116,"url":"https://www.federalregister.gov/agencies/drug-enforcement-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/116","parent_id":268,"slug":"drug-enforcement-administration"},{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"}],"excerpts":"(transfers to the <span class=\"match\">patient</span>) is $146,644 ($2.22 × 66,056). Subtracting the VA reimbursement amount from the total cost savings, DEA estimates a total <span class=\"match\">patient</span> net cost savings of $2,393,870 ($2,540,514 − $146,644) per year. Table 10 summarizes this calculation. \n \n Table 10—Total Cost/Transfer Savings \n \n   \n \n Total cost\n savings \n ($) \n \n \n VA\n reimbursement \n ($) \n \n \n <span class=\"match\">Patient</span> net\n cost savings \n ($) \n \n \n \n <span class=\"match\">Patient</span> cost savings (per visit) \n 38.46 \n 2.22 \n N/A \n \n \n <span class=\"match\">Patient</span> cost savings \n 2,540,514 \n 146,644 \n 2,393,870 \n \n \n e. <span class=\"match\">Patient</span> Benefit: Increased"},{"title":"Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability Standards and Prior Authorization for Drugs for Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Children's Health Insurance Program (CHIP) Agencies and CHIP Managed Care Entities, and Issuers of Qualified Health Plans on the Federally-Facilitated Exchanges","type":"Proposed Rule","abstract":"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.","document_number":"2026-07205","html_url":"https://www.federalregister.gov/documents/2026/04/14/2026-07205/medicare-and-medicaid-programs-patient-protection-and-affordable-care-act-interoperability-standards","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-14/pdf/2026-07205.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-07205.pdf?1775852111","publication_date":"2026-04-14","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"},{"raw_name":"Office of the Secretary"}],"excerpts":"of drugs covered by the payer under the <span class=\"match\">patient's</span> health plan through the <span class=\"match\">Patient</span> Access API. We believe that by requiring these IGs, impacted payers would format data available through the <span class=\"match\">Patient</span> Access API in a consistent manner that would allow health app developers to easily access and display <span class=\"match\">patients</span>' health data, thus having those data readily available and easily accessible to <span class=\"match\">patients</span>. Enabling <span class=\"match\">patients</span> to easily access their health information electronically through an API should allow <span class=\"match\">patients</span> to better manage their health care. \n (2)"},{"title":"Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2027; and Basic Health Program","type":"Rule","abstract":"This final rule contains provisions to improve implementation of the Patient Protection and Affordable Care Act, including payment parameters and provisions related to the HHS-operated risk adjustment and risk adjustment data validation (HHS-RADV) programs, as well as 2027 user fee rates for issuers offering qualified health plans (QHPs) through Federally-facilitated Exchanges (FFEs) and State-based Exchanges on the Federal platform (SBE-FPs). This final rule also includes provisions related to civil money penalties (CMPs) for noncompliant issuers and other responsible entities; standards governing agents, brokers, and web-brokers; the expansion and codification of hardship exemption eligibility; implementation of the State Exchange Improper Payment Measurement (SEIPM); provider access standards and essential community provider standards for QHP certification; QHP certification of non-network plans; a prohibition on issuers from including routine non-pediatric dental services as an Essential Health Benefit (EHB); requirements related to defrayal for the cost of any State-required benefits in addition to the EHB; cost- sharing flexibilities for catastrophic and individual market bronze plans; establishment of catastrophic plans with plan terms of up to 10 consecutive plan years; QHP issuer quality improvement strategies (QISs); and revisions affecting which enrollees are included in Federal Basic Health Program (BHP) payment calculations to States. This final rule also includes amendments to implement certain provisions of the Working Families Tax Cut (WFTC) legislation.","document_number":"2026-10050","html_url":"https://www.federalregister.gov/documents/2026/05/20/2026-10050/patient-protection-and-affordable-care-act-hhs-notice-of-benefit-and-payment-parameters-for-2027-and","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-20/pdf/2026-10050.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-10050.pdf?1779135308","publication_date":"2026-05-20","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"},{"raw_name":"Office of the Secretary"}],"excerpts":"finalizing this policy as proposed. See the above preamble for additional discussion of the <span class=\"match\">impact</span> of section 71302 of the WFTC legislation on Federal BHP payments.\n \n \n Comment: \n Some commenters stated concern for the <span class=\"match\">impact</span> this proposal will have on the BHP. These commenters were concerned regarding the potential for coverage loss and churn between insurance affordability programs, the <span class=\"match\">impact</span> on coverage affordability and uncompensated care, and the <span class=\"match\">impact</span> on State government finances and State policy flexibility. Relatedly, several commenters"},{"title":"Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2027; and Basic Health Program","type":"Proposed Rule","abstract":"This proposed rule contains provisions to improve implementation of the Patient Protection and Affordable Care Act, including payment parameters and provisions related to the HHS-operated risk adjustment and risk adjustment data validation (HHS-RADV) programs, as well as 2027 user fee rates for issuers offering qualified health plans (QHPs) through Federally-facilitated Exchanges (FFEs) and State-based Exchanges on the Federal platform (SBE-FPs). This proposed rule also includes provisions related to civil money penalties (CMPs) for noncompliant issuers and other responsible entities; standards governing agents, brokers, and web-brokers; the expansion and codification of hardship exemption eligibility; implementation of the State Exchange Improper Payment Measurement (SEIPM); provider access standards and essential community provider standards for QHP certification; QHP certification of non-network plans; a prohibition on issuers from including routine non-pediatric dental services as an Essential Health Benefit (EHB); cost-sharing flexibilities for catastrophic and individual market bronze plans; establishment of catastrophic plans with plan terms of up to 10 consecutive years; QHP issuer quality improvement strategies (QISs); revisions affecting which enrollees are included in Federal Basic Health Program (BHP) payment calculations to States; and seeks comment on potential adjustments to other Federal standards, including the Federal medical loss ratio (MLR) standard in the individual market. This proposed rule also includes amendments to implement certain provisions of the Working Families Tax Cut (WFTC) legislation.","document_number":"2026-02769","html_url":"https://www.federalregister.gov/documents/2026/02/11/2026-02769/patient-protection-and-affordable-care-act-hhs-notice-of-benefit-and-payment-parameters-for-2027-and","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-02-11/pdf/2026-02769.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-02769.pdf?1770671709","publication_date":"2026-02-11","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"},{"raw_name":"Office of the Secretary"}],"excerpts":"Response to Comments \n VI. Regulatory <span class=\"match\">Impact</span> Analysis \n A. Statement of Need \n B. Overall <span class=\"match\">Impact</span> \n C. <span class=\"match\">Impact</span> Estimates of the Proposed Payment Notice Provisions and Accounting Table \n D. Regulatory Alternatives Considered \n E. Regulatory Flexibility Act (RFA) \n F. Unfunded Mandates Reform Act (UMRA) \n G. Federalism \n H. E.O. 14192, “Unleashing Prosperity Through Deregulation” \n \n I. Executive Summary \n \n We propose changes to the provisions and parameters implemented through prior rulemaking to implement the <span class=\"match\">Patient</span> Protection and Affordable Care Act"},{"title":"Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability","type":"Proposed Rule","abstract":"This proposed rule seeks to advance interoperability, improve transparency, and support the access, exchange, and use of electronic health information through proposals for: standards adoption; adoption of certification criteria to advance public health data exchange; expanded uses of certified application programming interfaces, such as for electronic prior authorization, patient access, care management, and care coordination; and information sharing under the information blocking regulations. It proposes to establish a new baseline version of the United States Core Data for Interoperability. The proposed rule would update the ONC Health IT Certification Program to enhance interoperability and optimize certification processes to reduce burden and costs. The proposed rule would also implement certain provisions related to the Trusted Exchange Framework and Common Agreement (TEFCA), which would support the reliability, privacy, security, and trust within TEFCA.","document_number":"2024-14975","html_url":"https://www.federalregister.gov/documents/2024/08/05/2024-14975/health-data-technology-and-interoperability-patient-engagement-information-sharing-and-public-health","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-08-05/pdf/2024-14975.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-14975.pdf?1721825115","publication_date":"2024-08-05","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Office of the Secretary"}],"excerpts":"The data element in the <span class=\"match\">Patient</span> Summary and Plan data class is Assessment and Plan of Treatment. \n • The data elements in <span class=\"match\">Problems</span> include <span class=\"match\">Problems</span>, SDOH <span class=\"match\">Problems</span>/Health Concerns, Date of Diagnosis, and Date of Resolution. \n We selected these data classes based on feedback from industry and existing industry support as well as our understanding of importance for improved <span class=\"match\">patient</span> care. We believe that the standards referenced for these data elements are mature enough or the information they relay are important enough to <span class=\"match\">patient</span> care to warrant inclusion"},{"title":"Patient Protection and Affordable Care Act; Marketplace Integrity and Affordability","type":"Rule","abstract":"This final rule revises standards relating to denial of coverage for failure to pay past-due premium; excludes Deferred Action for Childhood Arrivals recipients from the definition of \"lawfully present;\" establishes the evidentiary standard HHS uses to assess an agent's, broker's, or web-broker's potential noncompliance; revises the Exchange automatic reenrollment hierarchy; revises standards related to the annual open enrollment period and special enrollment periods; revises standards relating to failure to file and reconcile, income eligibility verifications for premium tax credits and cost-sharing reductions, annual eligibility redeterminations, de minimis thresholds for the actuarial value for plans subject to essential health benefits (EHB) requirements, and income-based cost-sharing reduction plan variations. This final rule also revises the premium adjustment percentage methodology and prohibits issuers of coverage subject to EHB requirements from providing coverage for specified sex-trait modification procedures as an EHB.","document_number":"2025-11606","html_url":"https://www.federalregister.gov/documents/2025/06/25/2025-11606/patient-protection-and-affordable-care-act-marketplace-integrity-and-affordability","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-06-25/pdf/2025-11606.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-11606.pdf?1750709712","publication_date":"2025-06-25","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"}],"excerpts":"negatively <span class=\"match\">impact</span> the risk pool. At that time, we did not analyze the experience of people applying for SEPs to assess the <span class=\"match\">impact</span> on the risk pool. Rather, it was our perception that the extra step required by verification can deter eligible consumers from enrolling in coverage through an SEP, which in turn, can negatively <span class=\"match\">impact</span> the risk pool because younger, often healthier, consumers submit acceptable documentation to verify their SEP eligibility at much lower rates than older consumers. To mitigate this potential negative <span class=\"match\">impact</span> on the risk"},{"title":"Patient Protection and Affordable Care Act; Marketplace Integrity and Affordability","type":"Proposed Rule","abstract":"This proposed rule would revise standards relating to past-due premium payments; exclude Deferred Action for Childhood Arrivals recipients from the definition of \"lawfully present\"; the evidentiary standard HHS uses to assess an agent's, broker's, or web-broker's potential noncompliance; failure to file and reconcile; income eligibility verifications for premium tax credits and cost-sharing reductions; annual eligibility redetermination; the automatic reenrollment hierarchy; the annual open enrollment period; special enrollment periods; de minimis thresholds for the actuarial value for plans subject to essential health benefits (EHB) requirements and for income-based cost-sharing reduction plan variations; and the premium adjustment percentage methodology; and prohibit issuers of coverage subject to EHB requirements from providing coverage for sex-trait modification as an EHB.","document_number":"2025-04083","html_url":"https://www.federalregister.gov/documents/2025/03/19/2025-04083/patient-protection-and-affordable-care-act-marketplace-integrity-and-affordability","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-03-19/pdf/2025-04083.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-04083.pdf?1741810509","publication_date":"2025-03-19","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"}],"excerpts":"negatively <span class=\"match\">impact</span> the risk pool. At that time, we did not analyze the experience of people applying for SEPs to assess the <span class=\"match\">impact</span> on the risk pool. Rather, it was our perception that the extra step required by verification can deter eligible consumers from enrolling in coverage through an SEP, which in turn, can negatively <span class=\"match\">impact</span> the risk pool because younger, often healthier, consumers submit acceptable documentation to verify their SEP eligibility at much lower rates than older consumers. To mitigate this potential negative <span class=\"match\">impact</span> on the risk"},{"title":"Confidentiality of Substance Use Disorder (SUD) Patient Records","type":"Rule","abstract":"The United States Department of Health and Human Services (HHS or \"Department\") is issuing this final rule to modify its regulations to implement section 3221 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The Department is issuing this final rule after careful consideration of all public comments received in response to the notice of proposed rulemaking (NPRM) for the Confidentiality of Substance Use Disorder (SUD) Patient Records. This final rule also makes certain other modifications to increase alignment with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to improve workability and decrease burden on programs, covered entities, and business associates.","document_number":"2024-02544","html_url":"https://www.federalregister.gov/documents/2024/02/16/2024-02544/confidentiality-of-substance-use-disorder-sud-patient-records","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-02-16/pdf/2024-02544.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-02544.pdf?1707408916","publication_date":"2024-02-16","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Office of the Secretary"}],"excerpts":"14—Minor <span class=\"match\">Patients</span> \n Finalizes the change of the verb “judges” to “determines” to describe a part 2 program director's evaluation and decision that a minor lacks decision making capacity. \n 9. Section 2.15—<span class=\"match\">Patients</span> Who Lack Capacity and Deceased <span class=\"match\">Patients</span> \n Finalizes changes proposed in the NPRM. Changes the heading as above. Replaces outdated terminology and clarifies that paragraph (a) of this section refers to an adjudication by a court of a <span class=\"match\">patient's</span> lack of capacity to make health care decisions while paragraph (b) refers to a <span class=\"match\">patient's</span> lack of"},{"title":"United States, et al. v. UnitedHealth Group Incorporated, et al.; Proposed Final Judgment and Competitive Impact Statement","type":"Notice","abstract":null,"document_number":"2025-15486","html_url":"https://www.federalregister.gov/documents/2025/08/14/2025-15486/united-states-et-al-v-unitedhealth-group-incorporated-et-al-proposed-final-judgment-and-competitive","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-08-14/pdf/2025-15486.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-15486.pdf?1755089133","publication_date":"2025-08-14","agencies":[{"raw_name":"DEPARTMENT OF JUSTICE","name":"Justice Department","id":268,"url":"https://www.federalregister.gov/agencies/justice-department","json_url":"https://www.federalregister.gov/api/v1/agencies/268","parent_id":null,"slug":"justice-department"},{"raw_name":"Antitrust Division","name":"Antitrust Division","id":23,"url":"https://www.federalregister.gov/agencies/antitrust-division","json_url":"https://www.federalregister.gov/api/v1/agencies/23","parent_id":268,"slug":"antitrust-division"}],"excerpts":"nurses develop close and meaningful relationships with <span class=\"match\">patients</span>, which many nurses find particularly fulfilling. These nurses spend hours with <span class=\"match\">patients</span> in their homes to provide care and comfort, which can influence <span class=\"match\">patients</span>' recovery and satisfaction with care. Thus, <span class=\"match\">patients</span> benefit when home health and hospice providers attract high quality, compassionate nurses who can help improve <span class=\"match\">patients</span>' condition or care for them in their final days. \n \n 26. Within home health and hospice, Medicare regulations and state licensure laws distinguish between two"},{"title":"Immunology and Microbiology Devices; Reclassification of Nucleic Acid-Based Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product; Proposed Amendment; Proposed Order; Request for Comments","type":"Proposed Rule","abstract":"The Food and Drug Administration (FDA) is proposing to reclassify certain postamendments class III nucleic acid-based test systems indicated for use with a corresponding approved oncology therapeutic product (product codes OWD, PJG, PQP, and SFL) from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation, along with the special controls that FDA believes are necessary to provide a reasonable assurance of safety and effectiveness for these devices.","document_number":"2025-21071","html_url":"https://www.federalregister.gov/documents/2025/11/25/2025-21071/immunology-and-microbiology-devices-reclassification-of-nucleic-acid-based-test-systems-for-use-with","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-11-25/pdf/2025-21071.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-21071.pdf?1763991946","publication_date":"2025-11-25","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"account for the device <span class=\"match\">problem</span> associated with a significant number (over 80 percent) of the MDR reported events. Other device <span class=\"match\">problems</span> that were less frequently reported include, for example, incorrect, inadequate or imprecise result or readings, non-reproducible results, output <span class=\"match\">problem</span>, and false negative results. Notably, a significant majority (over 95 percent) of the MDRs reported under these product codes listed identified no clinical signs, symptoms, or conditions; no <span class=\"match\">known</span> <span class=\"match\">impact</span> or <span class=\"match\">consequence</span> to the <span class=\"match\">patient</span>; and/or no <span class=\"match\">patient</span> involvement. Other"},{"title":"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Obtaining Information To Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities","type":"Notice","abstract":"The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.","document_number":"2025-07557","html_url":"https://www.federalregister.gov/documents/2025/05/01/2025-07557/agency-information-collection-activities-submission-for-office-of-management-and-budget-review","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-05-01/pdf/2025-07557.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-07557.pdf?1746017115","publication_date":"2025-05-01","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"by outsourcing facilities. Generally, drug compounding is the practice of combining, mixing, or altering ingredients of a drug to create a medication tailored to an individual <span class=\"match\">patient's</span> needs. Although compounded drugs can serve an important medical need for certain <span class=\"match\">patients</span> when an approved drug is not medically appropriate, compounded drugs also present a risk to <span class=\"match\">patients</span>. Compounded drugs are not FDA-approved; therefore, they do not undergo FDA premarket review for safety, effectiveness, and quality. \n Section 503A of the Federal Food, Drug, and"},{"title":"Abnormal Occurrence Reporting","type":"Notice","abstract":"The U.S. Nuclear Regulatory Commission (NRC) is issuing a limited revision to its policy statement on reporting abnormal occurrences (AOs) to Congress. The revised policy statement provides more specific language to the medical event criteria to better identify those incidents and events that the Commission considers significant from the standpoint of public health or safety. The revised AO criteria contain additional language to add clarity, helping to delineate abnormal occurrence events from nonreportable events which may have been reviewed under the previous criteria.","document_number":"2025-15293","html_url":"https://www.federalregister.gov/documents/2025/08/12/2025-15293/abnormal-occurrence-reporting","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-08-12/pdf/2025-15293.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-15293.pdf?1754916323","publication_date":"2025-08-12","agencies":[{"raw_name":"NUCLEAR REGULATORY COMMISSION","name":"Nuclear Regulatory Commission","id":383,"url":"https://www.federalregister.gov/agencies/nuclear-regulatory-commission","json_url":"https://www.federalregister.gov/api/v1/agencies/383","parent_id":null,"slug":"nuclear-regulatory-commission"}],"excerpts":"specific hazards, <span class=\"match\">consequences</span>, and those controls used to prevent or mitigate the <span class=\"match\">consequences</span> of such accidents. For these facilities, a high-<span class=\"match\">consequence</span> event would be a release that has the potential to cause acute radiological or chemical exposures to a worker or a member of the public similar to that defined in Appendix A to Chapter 3, Section A.2, of NUREG-1520, Revision 2, “Standard Review Plan for Fuel Cycle Facilities License Applications—Final Report,” issued June 2015, under “<span class=\"match\">Consequence</span> Category 3 (High <span class=\"match\">Consequences</span>)” (ADAMS Accession"},{"title":"Ensuring Safe Accommodations for Air Travelers With Disabilities Using Wheelchairs","type":"Rule","abstract":"The U.S. Department of Transportation (DOT or the Department) is issuing a final rule to strengthen its regulation implementing the Air Carrier Access Act (ACAA) and to address the serious problems that individuals with disabilities using wheelchairs and scooters face when traveling by air that impact their safety and dignity, including mishandled wheelchairs and scooters and improper transfers to and from aircraft seats, aisle chairs, and personal wheelchairs. This final rule also carries out certain rulemaking provisions required by the FAA Reauthorization Act of 2024.","document_number":"2024-29731","html_url":"https://www.federalregister.gov/documents/2024/12/17/2024-29731/ensuring-safe-accommodations-for-air-travelers-with-disabilities-using-wheelchairs","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-12-17/pdf/2024-29731.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-29731.pdf?1734356740","publication_date":"2024-12-17","agencies":[{"raw_name":"DEPARTMENT OF TRANSPORTATION","name":"Transportation Department","id":492,"url":"https://www.federalregister.gov/agencies/transportation-department","json_url":"https://www.federalregister.gov/api/v1/agencies/492","parent_id":null,"slug":"transportation-department"},{"raw_name":"Office of the Secretary"}],"excerpts":"environmental <span class=\"match\">impacts</span> of this final action pursuant to the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321 \n et seq. \n ) and has determined that it is categorically excluded pursuant to DOT Order 5610.1C, Procedures for Considering Environmental <span class=\"match\">Impacts</span> (44 Fed. Red. 56420, Oct. 1, 1979). Categorical exclusions are actions identified in an agency's NEPA implementing procedures that do not normally have a significant <span class=\"match\">impact</span> on the environment and therefore do not require either an environmental assessment (EA) or environmental <span class=\"match\">impact</span> statement"},{"title":"HHS Request for Comment on Chronic Disease of Addiction","type":"Notice","abstract":"Thanks to President Trump's leadership, since 2017, the country has made significant progress in addressing mental health and substance use. However, President Trump and HHS Secretary Kennedy realize that the Department and country have more work to do. To facilitate this effort, HHS invites public comment in response to this RFI on the research, development, programs, and policies that have been most successful in improving availability of and access to effective prevention, treatment, and recovery interventions for addiction, mental illness, and co-occurring substance use and mental disorders. The purpose of this RFI is to identify research, programs, and policies that have been successful and recommend novel policy ideas and gaps in research that could be addressed and implemented to further the Great American Recovery using existing funding.","document_number":"2026-11602","html_url":"https://www.federalregister.gov/documents/2026/06/10/2026-11602/hhs-request-for-comment-on-chronic-disease-of-addiction","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-10/pdf/2026-11602.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-11602.pdf?1780931706","publication_date":"2026-06-10","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"}],"excerpts":"to improve <span class=\"match\">patient</span> health outcomes. The final rule provides the public with the ability to file complaints alleging violations of the Part 2 confidentiality provisions, requires Part 2 programs to provide notification of breaches of Part 2 records, and implements in regulation HHS's civil enforcement authority, including the potential for civil money penalties for violations.\n 5 \n \n SAMHSA is reissuing funding for a Center of Excellence in Privacy of Health Information that will support integration and use of data compliance with <span class=\"match\">patient</span> privacy protections"},{"title":"Ophthalmic Practice Rules (Eyeglass Rule)","type":"Rule","abstract":"The Federal Trade Commission (\"FTC\" or \"Commission\") is publishing a final rule to implement amendments to the Ophthalmic Practice Rules (\"Eyeglass Rule\" or \"Rule\"). These amendments require that prescribing eye care practitioners obtain a signed confirmation after releasing an eyeglass prescription to a patient and maintain each such confirmation for a period of not less than three years. The Commission is permitting prescribers to comply with automatic prescription release via electronic delivery if they first obtain verifiable affirmative consent from the patient and maintain a record of such consent for a period of not less than three years. The amendments further clarify that the presentation of proof of insurance coverage shall be deemed to be a payment for the purpose of determining when a prescription must be provided. Finally, the Commission amends the term \"eye examination\" to \"refractive eye examination\" throughout the Rule.","document_number":"2024-15620","html_url":"https://www.federalregister.gov/documents/2024/07/26/2024-15620/ophthalmic-practice-rules-eyeglass-rule","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-07-26/pdf/2024-15620.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-15620.pdf?1721911513","publication_date":"2024-07-26","agencies":[{"raw_name":"FEDERAL TRADE COMMISSION","name":"Federal Trade Commission","id":192,"url":"https://www.federalregister.gov/agencies/federal-trade-commission","json_url":"https://www.federalregister.gov/api/v1/agencies/192","parent_id":null,"slug":"federal-trade-commission"}],"excerpts":"sell that <span class=\"match\">patient</span> eyeglasses, the prescriber must release a copy of the prescription to the <span class=\"match\">patient</span> before moving forward with any aspect of the sale. If the prescription is released electronically (with the <span class=\"match\">patient's</span> consent), it must be uploaded to a <span class=\"match\">patient</span> portal or transmitted to the <span class=\"match\">patient</span> via email or text, and thus fully accessible to the <span class=\"match\">patient</span> before that <span class=\"match\">patient</span> is offered an opportunity to purchase eyewear. It also means that if the prescriber makes a medical determination to not write and release a prescription to a <span class=\"match\">patient</span>,\n 182 \n"},{"title":"Medicare Program; Treatment of Medicare Part C Days in the Calculation of a Hospital's Medicare Disproportionate Patient Percentage","type":"Rule","abstract":"This final action establishes a policy concerning the treatment of patient days associated with persons enrolled in a Medicare Part C (also known as \"Medicare Advantage\") plan for purposes of calculating a hospital's disproportionate patient percentage for cost reporting periods starting before fiscal year (FY) 2014 in response to the Supreme Court's ruling in Azar v. Allina Health Services, 139 S. Ct. 1804 (June 3, 2019).","document_number":"2023-12308","html_url":"https://www.federalregister.gov/documents/2023/06/09/2023-12308/medicare-program-treatment-of-medicare-part-c-days-in-the-calculation-of-a-hospitals-medicare","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-06-09/pdf/2023-12308.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-12308.pdf?1686168916","publication_date":"2023-06-09","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"the hospital, and the hospital's disproportionate <span class=\"match\">patient</span> percentage (DPP). A hospital's DPP is the sum of two fractions: the “Medicare fraction” and the “Medicaid fraction.” The Medicare fraction (also <span class=\"match\">known</span> as the SSI fraction or SSI ratio) is computed by dividing the number of the hospital's inpatient days that are furnished to <span class=\"match\">patients</span> who were entitled to both Medicare Part A and Supplemental Security Income (SSI) benefits by the hospital's total number of <span class=\"match\">patient</span> days furnished to <span class=\"match\">patients</span> entitled to benefits under Medicare Part A. The Medicaid"},{"title":"Medicare Program; Alternative Payment Model Updates and the Increasing Organ Transplant Access (IOTA) Model","type":"Rule","abstract":"This final rule describes a new mandatory alternative payment model, the Increasing Organ Transplant Access Model (IOTA Model), that will test whether performance-based upside risk payments or downside risk payments paid to or owed by participating kidney transplant hospitals increase access to kidney transplants for patients with end- stage renal disease (ESRD) while preserving or enhancing the quality of care and reducing Medicare expenditures. This final rule also adopts standard provisions that will apply to the Radiation Oncology Model, the End-Stage Renal Disease (ESRD) Treatment Choices Model, and mandatory Innovation Center models, including the IOTA Model, whose first performance period begins on or after January 1, 2025. The finalized standard provisions relate to beneficiary protections; cooperation in model evaluation and monitoring; audits and records retention; rights in data and intellectual property; monitoring and compliance; remedial action; model termination by CMS; limitations on review; miscellaneous provisions on bankruptcy and other notifications; and the reconsideration review process.","document_number":"2024-27841","html_url":"https://www.federalregister.gov/documents/2024/12/04/2024-27841/medicare-program-alternative-payment-model-updates-and-the-increasing-organ-transplant-access-iota","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-12-04/pdf/2024-27841.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-27841.pdf?1732655723","publication_date":"2024-12-04","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"enhance <span class=\"match\">patients</span>' survival and life experience, as well as to reduce the <span class=\"match\">impact</span> to Medicare. The IOTA Model aims to improve <span class=\"match\">patient</span> outcomes by incentivizing increased access to kidney transplantation across IOTA participants. Access to this lifesaving treatment may delay or avert dialysis, reduce costs to the Medicare program and to <span class=\"match\">patients</span>, and enhance survival and quality of life. \n \n A kidney transplant involves surgically transplanting a kidney from a living or deceased donor to a kidney transplant recipient. The replacement organ is <span class=\"match\">known</span> as a"},{"title":"Special Registrations for Telemedicine and Limited State Telemedicine Registrations","type":"Proposed Rule","abstract":"The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the \"Ryan Haight Act\") generally requires an in-person medical evaluation prior to the issuance of a prescription of controlled substances but provides an exception to this in-person medical evaluation requirement where the practitioner is engaged in the \"practice of telemedicine\" within the meaning of the Ryan Haight Act. These proposed regulatory changes would establish a Special Registration framework and authorize three types of Special Registration. This proposed rulemaking also provides for heightened prescription, recordkeeping, and reporting requirements. DEA believes such changes are necessary to effectively expand patient access to controlled substance medications via telemedicine while mitigating the risks of diversion associated with such expansion. A summary of this rule may be found at https://www.regulations.gov/docket/DEA-2023-0029.","document_number":"2025-01099","html_url":"https://www.federalregister.gov/documents/2025/01/17/2025-01099/special-registrations-for-telemedicine-and-limited-state-telemedicine-registrations","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-01-17/pdf/2025-01099.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-01099.pdf?1736948758","publication_date":"2025-01-17","agencies":[{"raw_name":"DEPARTMENT OF JUSTICE","name":"Justice Department","id":268,"url":"https://www.federalregister.gov/agencies/justice-department","json_url":"https://www.federalregister.gov/api/v1/agencies/268","parent_id":null,"slug":"justice-department"},{"raw_name":"Drug Enforcement Administration","name":"Drug Enforcement Administration","id":116,"url":"https://www.federalregister.gov/agencies/drug-enforcement-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/116","parent_id":268,"slug":"drug-enforcement-administration"}],"excerpts":"the <span class=\"match\">patient</span> with other forms of documentation, and would require the \n clinician special registrant \n to maintain a record of how they verified the <span class=\"match\">patient's</span> identity and what documents were used to verify the <span class=\"match\">patient's</span> identity. For example, a \n clinician special registrant \n (or their delegated employee or contractor under their direct supervision) might verify <span class=\"match\">patient</span> identity by observing a <span class=\"match\">patient's</span> pay stub and/or a bill with the <span class=\"match\">patient's</span> home address, a letter provided by a shelter employee if the <span class=\"match\">patient</span> is unhoused, or a <span class=\"match\">patient's</span> school"},{"title":"Andrew Konen, M.D.; Decision and Order","type":"Notice","abstract":null,"document_number":"2025-15866","html_url":"https://www.federalregister.gov/documents/2025/08/20/2025-15866/andrew-konen-md-decision-and-order","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-08-20/pdf/2025-15866.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-15866.pdf?1755607522","publication_date":"2025-08-20","agencies":[{"raw_name":"DEPARTMENT OF JUSTICE","name":"Justice Department","id":268,"url":"https://www.federalregister.gov/agencies/justice-department","json_url":"https://www.federalregister.gov/api/v1/agencies/268","parent_id":null,"slug":"justice-department"},{"raw_name":"Drug Enforcement Administration","name":"Drug Enforcement Administration","id":116,"url":"https://www.federalregister.gov/agencies/drug-enforcement-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/116","parent_id":268,"slug":"drug-enforcement-administration"}],"excerpts":"These changes do not <span class=\"match\">impact</span> this Decision/Order.\n \n \n \n In another provision, Texas law sets out “minimum requirements for the treatment of chronic pain” that, along with compliance with the generally accepted standard of care, are how the physician's treatment of a <span class=\"match\">patient's</span> pain will be evaluated.\n \n 20 \n \n Id. \n § 170.3. Those “minimum requirements” include evaluating the <span class=\"match\">patient</span> by obtaining a medical history and a physical examination “that includes a <span class=\"match\">problem</span>-focused exam specific to the chief presenting complaint of the <span class=\"match\">patient</span>.” \n Id. \n § 170"},{"title":"Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product","type":"Proposed Rule","abstract":"The Food and Drug Administration (FDA) is proposing to reclassify in situ hybridization (ISH) test systems indicated for use with a corresponding approved oncology therapeutic product (product codes NYQ, MVD, OWE, and PNK) from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation, along with the special controls that FDA believes are necessary to provide a reasonable assurance of safety and effectiveness for this device type.","document_number":"2025-10549","html_url":"https://www.federalregister.gov/documents/2025/06/11/2025-10549/hematology-and-pathology-devices-reclassification-of-in-situ-hybridization-test-systems-for-use-with","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-06-11/pdf/2025-10549.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-10549.pdf?1749559513","publication_date":"2025-06-11","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"80 percent) of the MDRs reported under the product codes listed have identified no <span class=\"match\">known</span> <span class=\"match\">impact</span> or <span class=\"match\">consequence</span> to <span class=\"match\">patient</span>, no <span class=\"match\">patient</span> involvement, and/or no clinical signs, symptoms, or conditions. After review of the data, the Agency has determined that broken control slides account for the device <span class=\"match\">problem</span> associated with nearly one-third of the MDR reported events, with other reported device <span class=\"match\">problems</span> including, for example, communication or transmission <span class=\"match\">problem</span>, false negative result, false positive result, and device operates differently than"}]}