{"description":"Documents matching 'patient device interaction problem'","count":1085,"total_pages":50,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bterm%5D=patient+device+interaction+problem&format=json&page=2","results":[{"title":"Medical Devices; Radiology Devices; Classification of Blood Irradiators","type":"Proposed Rule","abstract":"The Food and Drug Administration (FDA) is proposing to classify blood irradiator devices (product code MOT), unclassified preamendments devices, as follows: blood irradiator devices intended to prevent transfusion-associated graft-versus-host disease into class II (special controls) with premarket notification and blood irradiator devices intended to prevent metastasis into class III (premarket approval) to provide a reasonable assurance of safety and effectiveness of these devices. Elsewhere in this issue of the Federal Register, FDA is issuing a proposed order proposing to require the filing of a premarket approval application for blood irradiator devices intended to prevent metastasis.","document_number":"2026-05320","html_url":"https://www.federalregister.gov/documents/2026/03/18/2026-05320/medical-devices-radiology-devices-classification-of-blood-irradiators","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-03-18/pdf/2026-05320.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-05320.pdf?1773751519","publication_date":"2026-03-18","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":"that these <span class=\"match\">devices</span> are substantially equivalent to <span class=\"match\">device</span>(s) of the same type that were in commercial distribution prior to passage of the Medical <span class=\"match\">Device</span> Amendments on May 28, 1976. On May 26, 2005, FDA cleared the Raycell X-ray Blood Irradiator <span class=\"match\">device</span> (K051065). The Raycell X-ray Blood Irradiator is the first <span class=\"match\">device</span> to include, in addition to an intended use for the prevention of TA-GVHD, a second intended use for the prevention of metastasis.\n 5 \n \n To date, FDA has cleared a total of 16 <span class=\"match\">devices</span> under product code MOT. Two of the <span class=\"match\">devices</span> are cleared"},{"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":"of <span class=\"match\">devices</span> are class I (general controls), class II (special controls), and class III (premarket approval). \n \n Section 513(a)(1) of the FD&amp;C Act defines the three classes of <span class=\"match\">devices</span>. Class I <span class=\"match\">devices</span> are those <span class=\"match\">devices</span> for which the general controls of the FD&amp;C Act (controls authorized by or under section 501, 502, 510, 516, 518, 519, or 520 (21 U.S.C. 351, 352, 360, 360f, 360h, 360i, or 360j) or any combination of such sections) are sufficient to provide reasonable assurance of safety and effectiveness of the <span class=\"match\">device</span>; or those <span class=\"match\">devices</span> for"},{"title":"Medical Devices; Laboratory Developed Tests","type":"Rule","abstract":"The Food and Drug Administration is issuing a final rule to amend its regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. In conjunction with this amendment, the Food and Drug Administration is phasing out its general enforcement discretion approach for laboratory developed tests (LDTs) so that IVDs manufactured by a laboratory will generally fall under the same enforcement approach as other IVDs. This phaseout policy includes enforcement discretion policies for specific categories of IVDs manufactured by a laboratory, including currently marketed IVDs offered as LDTs and LDTs for unmet needs. This phaseout policy is intended to better protect the public health by helping to assure the safety and effectiveness of IVDs offered as LDTs, while also accounting for other important public health considerations such as patient access and reliance.","document_number":"2024-08935","html_url":"https://www.federalregister.gov/documents/2024/05/06/2024-08935/medical-devices-laboratory-developed-tests","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-05-06/pdf/2024-08935.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-08935.pdf?1714398256","publication_date":"2024-05-06","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":"as “preamendments <span class=\"match\">devices</span>”) are classified after FDA: (1) receives a recommendation from a <span class=\"match\">device</span> classification panel (an FDA advisory committee); (2) publishes the panel's recommendation, along with a proposed regulation classifying the <span class=\"match\">device</span>, and provides an opportunity for interested persons to submit comments; and (3) publishes a final regulation classifying the <span class=\"match\">device</span>. A preamendments <span class=\"match\">device</span> for which a classification regulation has not been promulgated is known as an “unclassified <span class=\"match\">device</span>.” Until an unclassified <span class=\"match\">device</span> type has been formally"},{"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":"Medication Adherence. \n • The data element in the Medical <span class=\"match\">Devices</span> data class is Unique <span class=\"match\">Device</span> Identifier—Implantable. \n • 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"},{"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":"collect more premiums or submit <span class=\"match\">patients</span> to higher cost sharing on the front end as a way to “entice” participants to remain in the plan for its duration do not align with the inherent purpose of these statutory limits to protect <span class=\"match\">patients</span> from untenable out-of-pocket costs in a given plan year and should not be allowed. However, this same commenter stated that, regarding mid-plan changes for multiple-year plans, if term changes would benefit the <span class=\"match\">patient</span>, such as reduced deductibles or cost sharing to entice a <span class=\"match\">patient</span> to remain enrolled in a particular"},{"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":"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":"unnecessary regulatory burden on interested parties, and improve affordability.\n \n \n \n 1 \n  The <span class=\"match\">Patient</span> Protection and Affordable Care Act (Pub. L. 111-148) was enacted on March 23, 2010. The Healthcare and Education Reconciliation Act of 2010 (Pub. L. 111-152), which amended and revised several provisions of the <span class=\"match\">Patient</span> Protection and Affordable Care Act, was enacted on March 30, 2010. In this rulemaking, the two statutes are referred to collectively as the “<span class=\"match\">Patient</span> Protection and Affordable Care Act” or “Affordable Care Act.”\n \n \n \n \n 2 \n  \n See \n sections"},{"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":"excess APTC a taxpayer must repay based on household income.\n \n \n \n 5 \n  The <span class=\"match\">Patient</span> Protection and Affordable Care Act (Pub. L. 111-148, 124 Stat. 119) was enacted on March 23, 2010. The Healthcare and Education Reconciliation Act of 2010 (Pub. L. 111-152, 124 Stat. 1049), which amended and revised several provisions of the <span class=\"match\">Patient</span> Protection and Affordable Care Act, was enacted on March 30, 2010. In this rulemaking, the two statutes are referred to collectively as the “<span class=\"match\">Patient</span> Protection and Affordable Care Act,” “Affordable Care Act,” or “ACA”.\n "},{"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":"Medicare Program; Calendar Year (CY) 2025 Home Health Prospective Payment System (HH PPS) Rate Update; HH Quality Reporting Program Requirements; HH Value-Based Purchasing Expanded Model Requirements; Home Intravenous Immune Globulin (IVIG) Items and Services Rate Update; and Other Medicare Policies","type":"Rule","abstract":"This final rule will set forth routine updates to the Medicare home health payment rates; the payment rate for the disposable negative pressure wound therapy (dNPWT) devices; and the intravenous immune globulin (IVIG) items and services payment rate for CY 2025 in accordance with existing statutory and regulatory requirements. In addition, it finalizes changes to the Home Health Quality Reporting Program (HH QRP) requirements and provides an update on potential approaches for integrating health equity in the Expanded Health Value Based Purchasing (HHVBP) Model. It also finalizes a new standard for an acceptance-to-service policy in the HH conditions of participation (CoPs). Lastly, it updates provider and supplier enrollment requirements and changes to the long-term care reporting requirements for acute respiratory illnesses.","document_number":"2024-25441","html_url":"https://www.federalregister.gov/documents/2024/11/07/2024-25441/medicare-program-calendar-year-cy-2025-home-health-prospective-payment-system-hh-pps-rate-update-hh","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-11-07/pdf/2024-25441.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-25441.pdf?1730492128","publication_date":"2024-11-07","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":"pressure wound therapy (dNPWT) <span class=\"match\">devices</span>, but such drugs and <span class=\"match\">devices</span> must be billed by the HHA while a <span class=\"match\">patient</span> is under a home health plan of care, as the law requires consolidated billing of osteoporosis drugs and dNPWT <span class=\"match\">devices</span>. \n \n To better align payment with <span class=\"match\">patient</span> care needs and to better ensure that clinically complex and ill beneficiaries have adequate access to home health care, in the CY 2019 HH PPS final rule with comment period (83 FR 56406), we finalized case-mix methodology refinements through the <span class=\"match\">Patient</span>-Driven Groupings Model (PDGM)"},{"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":"or other assistive <span class=\"match\">device</span> with a carrier and the carrier has control of a passenger's wheelchair, scooter, or other assistive <span class=\"match\">device</span>. An airline's custody begins when the passenger hands the <span class=\"match\">device</span> to an airline's representative or agent or leaves the wheelchair, scooter, or other assistive <span class=\"match\">device</span> at a location as instructed by the airline. An airline's custody ends when the passenger, or someone acting on behalf of the passenger, or another airline takes physical possession of the wheelchair, scooter, or other assistive <span class=\"match\">device</span>. This is consistent"},{"title":"Medical Devices; Laboratory Developed Tests","type":"Proposed Rule","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. In conjunction with this amendment, FDA is proposing a policy under which FDA intends to phase out its general enforcement discretion approach for laboratory developed tests (LDTs) so that IVDs manufactured by a laboratory would generally fall under the same enforcement approach as other IVDs. FDA is proposing this phaseout to better protect the public health by helping to assure the safety and effectiveness of LDTs. If finalized, this phaseout may also foster the manufacturing of innovative IVDs for which FDA has determined there is a reasonable assurance of safety and effectiveness.","document_number":"2023-21662","html_url":"https://www.federalregister.gov/documents/2023/10/03/2023-21662/medical-devices-laboratory-developed-tests","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-10-03/pdf/2023-21662.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-21662.pdf?1695991649","publication_date":"2023-10-03","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":"as “preamendments <span class=\"match\">devices</span>”) are classified after FDA: (1) receives a recommendation from a <span class=\"match\">device</span> classification panel (an FDA advisory committee); (2) publishes the panel's recommendation, along with a proposed regulation classifying the <span class=\"match\">device</span>, and provides an opportunity for interested persons to submit comments; and (3) publishes a final regulation classifying the <span class=\"match\">device</span>. A preamendments <span class=\"match\">device</span> for which a classification regulation has not been promulgated is known as an “unclassified <span class=\"match\">device</span>.” Until an unclassified <span class=\"match\">device</span> type has been formally"},{"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":"Health Data, Technology, and Interoperability: ASTP/ONC Deregulatory Actions To Unleash Prosperity","type":"Proposed Rule","abstract":"This proposed rule focuses on deregulatory actions identified in HHS regulations regarding Health information technology standards, implementation specifications, and certification criteria and certification programs for health information technology, and information blocking. This proposed rule seeks to reduce burden, offer flexibility to both developers and providers, and support innovation through the removal and revisions of certain certification criteria and regulatory provisions. This proposed rule also seeks to address reported misuse and abuse of information blocking definitions and exceptions.","document_number":"2025-23896","html_url":"https://www.federalregister.gov/documents/2025/12/29/2025-23896/health-data-technology-and-interoperability-astponc-deregulatory-actions-to-unleash-prosperity","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-12-29/pdf/2025-23896.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-23896.pdf?1766438109","publication_date":"2025-12-29","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":"these proposals. \n d. Implantable <span class=\"match\">Device</span> List \n We propose to remove and reserve the “implantable <span class=\"match\">device</span> list” certification criterion in § 170.315(a)(14). The implantable <span class=\"match\">device</span> list certification criterion requires Health IT Modules certified to § 170.315(a)(14) to exchange, record, and allow a user to access a list of Unique <span class=\"match\">Device</span> Identifiers (UDIs) associated with a <span class=\"match\">patient's</span> implantable <span class=\"match\">devices</span>. There is no adopted standard or implementation guide associated with this functionality. However, the implantable <span class=\"match\">device</span> list certification criterion is"},{"title":"Medicare and Medicaid Programs; CY 2025 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Prescription Drug Inflation Rebate Program; and Medicare Overpayments","type":"Rule","abstract":"This final rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; codification of establishment of new policies for, the Medicare Prescription Drug Inflation Rebate Program under the Inflation Reduction Act of 2022; updates to the Medicare Diabetes Prevention Program expanded model; payment for dental services inextricably linked to specific covered medical services; updates to drugs and biological products paid under Part B including immunosuppressive drugs and clotting factors; Medicare Shared Savings Program requirements; updates to the Quality Payment Program; Medicare coverage of opioid use disorder services furnished by opioid treatment programs; updates to policies for Rural Health Clinics and Federally Qualified Health Centers; electronic prescribing for controlled substances for a covered Part D drug under a prescription drug plan or a Medicare Advantage Prescription Drug (MA-PD) plan under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act); update to the Ambulance Fee Schedule regulations; codification of the Inflation Reduction Act and Consolidated Appropriations Act, 2023 provisions; updates to Clinical Laboratory Fee Schedule regulations; updates to the diabetes payment structure and PHE flexibilities; expansion of colorectal cancer screening and Hepatitis B vaccine coverage and payment; establishing payment for drugs covered as additional preventive services; Medicare Parts A and B Overpayment Provisions of the Affordable Care Act and Medicare Parts C and D Overpayment Provisions of the Affordable Care Act.","document_number":"2024-25382","html_url":"https://www.federalregister.gov/documents/2024/12/09/2024-25382/medicare-and-medicaid-programs-cy-2025-payment-policies-under-the-physician-fee-schedule-and-other","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-12-09/pdf/2024-25382.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-25382.pdf?1730492138","publication_date":"2024-12-09","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":"internal data, the <span class=\"match\">device</span> manufacturer stated that in 2023, 48 percent of WatchPAT tests used the disposable WatchPAT One <span class=\"match\">device</span>, reflecting a 4—8 percent annual increase since 2020; by the first half of 2024, this trend continued, with 53 percent of WatchPAT tests in the U.S. using the disposable HSAT <span class=\"match\">device</span>. Based on their utilization data and projections, the <span class=\"match\">device</span> manufacturer believed that there is strong evidence that the typical procedure in 2024 will involve the use of disposable rather than reusable HSAT equipment. The <span class=\"match\">device</span> manufacturer indicated"},{"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":"(“IOTA waitlist <span class=\"match\">patient</span>”); and (2) A kidney transplant <span class=\"match\">patient</span> who receives a kidney transplant at the age of 18 years or older from an IOTA participant at any time during the model performance period (“IOTA transplant <span class=\"match\">patient</span>”). These <span class=\"match\">patients</span> would be referred to as IOTA waitlist <span class=\"match\">patients</span> and IOTA transplant <span class=\"match\">patients</span>, respectively, for purposes of assessing each IOTA participant's performance across the achievement domain, efficiency domain, and quality domain as discussed in section III.C.5 of this final rule. IOTA waitlist <span class=\"match\">patients</span> and IOTA transplant"},{"title":"Medication Guides: Patient Medication Information","type":"Proposed Rule","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its human prescription drug product labeling regulations for Medication Guides (FDA-approved written prescription drug product information distributed to patients). This action, if finalized, will require applicants to create a new type of Medication Guide, referred to as Patient Medication Information (PMI), for prescription drug products, including biological products, used, dispensed, or administered on an outpatient basis and for blood and blood components transfused in an outpatient setting. PMI would be a one-page document with standardized format and content that would be submitted to FDA for approval. This proposed rule is intended to improve public health by providing patients with clear, concise, accessible, and useful written prescription drug product information delivered in a consistent and easily understood format to help patients use their prescription drug products safely and effectively.","document_number":"2023-11354","html_url":"https://www.federalregister.gov/documents/2023/05/31/2023-11354/medication-guides-patient-medication-information","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-05-31/pdf/2023-11354.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-11354.pdf?1685450721","publication_date":"2023-05-31","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":"is produced by voluntary private sector entities and is intended to provide general written <span class=\"match\">patient</span> prescription drug product information to <span class=\"match\">patients</span>. An Instructions for Use document is developed by applicants and is intended for <span class=\"match\">patients</span> who use prescription drug products that have complicated or detailed <span class=\"match\">patient</span>-use instructions. \n 1. <span class=\"match\">Patient</span> Package Insert (PPI) \n A PPI is written prescription drug product information developed by applicants for <span class=\"match\">patients</span>. Current FDA regulations require that applicants develop PPIs for oral contraceptives and"},{"title":"Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program","type":"Rule","abstract":"This major final rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; codification of establishment of new policies for: the Medicare Prescription Drug Inflation Rebate Program under the Inflation Reduction Act of 2022; the Ambulatory Specialty Model; updates to the Medicare Diabetes Prevention Program expanded model; updates to drugs and biological products paid under Part B; Medicare Shared Savings Program requirements; updates to the Quality Payment Program; updates to policies for Rural Health Clinics and Federally Qualified Health Centers; update to the Ambulance Fee Schedule regulations; codification of the Inflation Reduction Act and Consolidated Appropriations Act, 2023 provisions; updates to the Medicare Promoting Interoperability Program.","document_number":"2025-19787","html_url":"https://www.federalregister.gov/documents/2025/11/05/2025-19787/medicare-and-medicaid-programs-cy-2026-payment-policies-under-the-physician-fee-schedule-and-other","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-11-05/pdf/2025-19787.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-19787.pdf?1761945018","publication_date":"2025-11-05","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":"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":"same day, which suggests that the <span class=\"match\">interaction</span> between the clinical staff and the <span class=\"match\">patient</span> described by this service is severable from the kind of professional service that falls under the scope of section 1834(m) of the Act. We understand that before the broad adoption of telecommunications technology for <span class=\"match\">patient</span> <span class=\"match\">interactions</span> nearly 6 years ago, these <span class=\"match\">interactions</span> may have typically taken place in person, and we considered the request to add this service to the telehealth list in that context. However, the <span class=\"match\">interaction</span> described explicitly by the code"},{"title":"Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Overall Hospital Quality Star Rating; Hospital Price Transparency; and Notice of Closure of a Teaching Hospital and Opportunity To Apply for Available Slots","type":"Rule","abstract":"This final rule with comment period revises the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) payment system for calendar year 2026 based on our continuing experience with these systems. We also describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment systems. In addition, this final rule with comment period announces the closure of a teaching hospital and the opportunity to apply for available slots, and updates and refines the requirements for the Hospital Outpatient Quality Reporting Program, Rural Emergency Hospital Quality Reporting Program, Ambulatory Surgical Center Quality Reporting Program, Overall Hospital Quality Star Rating, and hospitals to make public their standard charge information and enforcement of hospital price transparency, as well as summarizes comments received in response to a request for information on measure concepts regarding Well-Being and Nutrition for consideration in future years for the OQR, REHQR, and ASCQR programs.","document_number":"2025-20907","html_url":"https://www.federalregister.gov/documents/2025/11/25/2025-20907/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-payment","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-11-25/pdf/2025-20907.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-20907.pdf?1763759710","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":"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":"Continuous EEG monitoring involves an implantable <span class=\"match\">device</span>. The <span class=\"match\">device</span> is an electroencephalographic (EEG) recording and transmitting <span class=\"match\">device</span> implanted under the scalp. It is a prescription <span class=\"match\">device</span> indicated to acquire, transmit, and store EEGs continuously from <span class=\"match\">patients</span> between 18-75 years of age with drug-resistant epilepsy who are intolerant or not indicated for more conservative monitoring tools. The <span class=\"match\">device</span> is intended to aid a physician's remote assessment and monitoring of the indicated <span class=\"match\">patient's</span> condition. \n The medical use of the data acquired"},{"title":"Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program and Value-Based Purchasing Program for Federal Fiscal Year 2025","type":"Rule","abstract":"This final rule finalizes changes and updates to the policies and payment rates used under the Skilled Nursing Facility (SNF) Prospective Payment System (PPS) for fiscal year (FY) 2025. First, we are rebasing and revising the SNF market basket to reflect a 2022 base year. Next, we update the wage index used under the SNF PPS to reflect data collected during the most recent decennial census. Additionally, we finalize several technical revisions to the code mappings used to classify patients under the Patient Driven Payment Model (PDPM) to improve payment and coding accuracy. This final rule also updates the requirements for the SNF Quality Reporting Program and the SNF Value- Based Purchasing Program. Finally, we also are revising CMS' enforcement authority for imposing civil money penalties (CMPs) and including revisions to strengthen nursing home enforcement regulations.","document_number":"2024-16907","html_url":"https://www.federalregister.gov/documents/2024/08/06/2024-16907/medicare-program-prospective-payment-system-and-consolidated-billing-for-skilled-nursing-facilities","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-08-06/pdf/2024-16907.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-16907.pdf?1722456916","publication_date":"2024-08-06","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 SNF clinical team. \n 4. <span class=\"match\">Patient</span> Experience of Care/<span class=\"match\">Patient</span> Satisfaction \n \n Comment: \n We received many comments on the concept of a <span class=\"match\">patient</span> experience of care/<span class=\"match\">patient</span> satisfaction measure, and all commenters supported the idea of further development. One commenter noted that the lack of a <span class=\"match\">patient</span> experience of care/<span class=\"match\">patient</span> satisfaction measure is a notable gap in quality measurement and <span class=\"match\">patient</span> reported measures should be given equal consideration as data driven measures in the SNF QRP. Two commenters called <span class=\"match\">patient</span> self-report the gold standard"}]}