{"description":"Documents matching 'audit provide feedback improve mammography'","count":140,"total_pages":7,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bterm%5D=audit+provide+feedback+improve+mammography&format=json&page=2","results":[{"title":"Mammography Quality Standards Act","type":"Rule","abstract":"The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule to update the mammography regulations that were issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). We are issuing updates to modernize the regulations by incorporating current science and mammography best practices. These updates are intended to improve the delivery of mammography services by strengthening the communication of healthcare information; allowing for more informed decision making by patients and providers (by requiring facilities to provide them with additional health information); helping to ensure the availability of qualified mammography personnel; bolstering the medical outcomes audit to provide feedback to improve mammography interpretations; modernizing technological aspects of the standards; and adding additional tools to deal with noncompliant facilities.","document_number":"2023-04550","html_url":"https://www.federalregister.gov/documents/2023/03/10/2023-04550/mammography-quality-standards-act","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-03-10/pdf/2023-04550.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-04550.pdf?1678369517","publication_date":"2023-03-10","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"},{"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":"rule to update the <span class=\"match\">mammography</span> regulations that were issued under the <span class=\"match\">Mammography</span> Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&amp;C Act). We are issuing updates to modernize the regulations by incorporating current science and <span class=\"match\">mammography</span> best practices. These updates are intended to <span class=\"match\">improve</span> the delivery of <span class=\"match\">mammography</span> services by strengthening the communication of healthcare information; allowing for more informed decision making by patients and providers (by requiring facilities to <span class=\"match\">provide</span> them with additional"},{"title":"Federal Independent Dispute Resolution Operations","type":"Rule","abstract":"This document sets forth these final rules related to certain provisions of the No Surprises Act regarding the Federal independent dispute resolution (IDR) process, which was established as part of the Consolidated Appropriations Act, 2021 (CAA). These rules finalize new requirements relating to the disclosure of information that group health plans and health insurance issuers offering group or individual health insurance coverage must include along with the initial payment or notice of denial of payment for certain items and services subject to the surprise billing protections in the No Surprises Act. These final rules also require plans and issuers to communicate information by using claim adjustment reason codes (CARCs) and remittance advice remark codes (RARCs), as specified in guidance, when providing any paper or electronic remittance advice (ERA) to an entity that does not have a contractual relationship with the plan or issuer. This document also finalizes amendments to certain requirements related to the open negotiation period preceding the Federal IDR process, the initiation of the Federal IDR process, the Federal IDR dispute eligibility review process, and the payment and collection of administrative fees and certified IDR entity fees. This document also finalizes the definition of bundled payment arrangements, amends requirements related to batched items and services and amends the rules for extensions of timeframes due to extenuating circumstances. Additionally, this document finalizes provisions that require plans and issuers to register in the Federal IDR portal. In accordance with Federal law, a summary of these rules may be found at https://www.regulations.gov/.","document_number":"2026-11140","html_url":"https://www.federalregister.gov/documents/2026/06/04/2026-11140/federal-independent-dispute-resolution-operations","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-04/pdf/2026-11140.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-11140.pdf?1780348210","publication_date":"2026-06-04","agencies":[{"raw_name":"OFFICE OF PERSONNEL MANAGEMENT","name":"Personnel Management Office","id":406,"url":"https://www.federalregister.gov/agencies/personnel-management-office","json_url":"https://www.federalregister.gov/api/v1/agencies/406","parent_id":null,"slug":"personnel-management-office"},{"raw_name":"DEPARTMENT OF THE TREASURY","name":"Treasury Department","id":497,"url":"https://www.federalregister.gov/agencies/treasury-department","json_url":"https://www.federalregister.gov/api/v1/agencies/497","parent_id":null,"slug":"treasury-department"},{"raw_name":"Internal Revenue Service","name":"Internal Revenue Service","id":254,"url":"https://www.federalregister.gov/agencies/internal-revenue-service","json_url":"https://www.federalregister.gov/api/v1/agencies/254","parent_id":497,"slug":"internal-revenue-service"},{"raw_name":"DEPARTMENT OF LABOR","name":"Labor Department","id":271,"url":"https://www.federalregister.gov/agencies/labor-department","json_url":"https://www.federalregister.gov/api/v1/agencies/271","parent_id":null,"slug":"labor-department"},{"raw_name":"Employee Benefits Security Administration","name":"Employee Benefits Security Administration","id":131,"url":"https://www.federalregister.gov/agencies/employee-benefits-security-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/131","parent_id":271,"slug":"employee-benefits-security-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":"and in the preamble to the 2023 proposed rules <span class=\"match\">provides</span> sufficient examples of bundled payment arrangements. The Departments restate the example in the preamble to the 2023 proposed rules: if a physician performs bilateral <span class=\"match\">mammography</span>, the provider shall report (or for the purpose of the Federal IDR process, the provider shall bill) the Current Procedural Terminology (CPT) code 77066 (\n Diagnostic <span class=\"match\">mammography</span> . . . bilateral \n ). The provider should not submit CPT code 77065 (\n Diagnostic <span class=\"match\">mammography</span> . . . unilateral \n ) with 2 UOS or CPT code 77065"},{"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":"specialty assignments list. Since these updates to the list have never been formally proposed in the CY 2026 PFS proposed rule (90 FR 32593 through 32597), there has been no opportunity for interested parties to comment and <span class=\"match\">provide</span> <span class=\"match\">feedback</span> before the assignments are finalized in the final rule. We believe that it would <span class=\"match\">provide</span> greater transparency and more opportunities for public comment if additions to the expected specialty assignments list were instead proposed in a future year's proposed rule.\n \n Therefore, we are not finalizing any additions"},{"title":"Medicare and Medicaid Programs; Contract Year 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly","type":"Rule","abstract":"This final rule revises the Medicare Advantage (Part C), Medicare Prescription Drug Benefit (Part D), Medicare cost plan, and Programs of All-Inclusive Care for the Elderly (PACE) regulations to implement changes related to prescription drug coverage, the Medicare Prescription Payment Plan, dual eligible special needs plans (D-SNPs), Part C and D Star Ratings, and other programmatic areas, including the Medicare Drug Price Negotiation Program. This final rule also codifies existing sub-regulatory guidance in the Part C and Part D programs.","document_number":"2025-06008","html_url":"https://www.federalregister.gov/documents/2025/04/15/2025-06008/medicare-and-medicaid-programs-contract-year-2026-policy-and-technical-changes-to-the-medicare","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-04-15/pdf/2025-06008.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-06008.pdf?1743797708","publication_date":"2025-04-15","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":"network pharmacies. CMS notes, however, that the requirement to <span class=\"match\">provide</span> the “Medicare Prescription Payment Plan Likely to Benefit Notice” in no way obligates the pharmacy to <span class=\"match\">provide</span> additional Medicare Prescription Payment Plan counseling or consultation to the Part D enrollee.\n \n In addition, pharmacies are encouraged, but not required, to <span class=\"match\">provide</span> educational material related to the Medicare Prescription Payment Plan, such as the CMS-developed fact sheet, at the time they <span class=\"match\">provide</span> an enrollee with the notice. \n \n Comment: \n Some commenters expressed"},{"title":"Medicare and Medicaid Programs; Contract Year 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly","type":"Proposed Rule","abstract":"This proposed rule would revise the Medicare Advantage (Part C), Medicare Prescription Drug Benefit (Part D), Medicaid, Medicare cost plan, and Programs of All-Inclusive Care for the Elderly (PACE) regulations to implement changes related to Star Ratings, marketing and communications, agent/broker compensation, health equity, drug coverage, dual eligible special needs plans (D-SNPs), utilization management, network adequacy, and other programmatic areas, including the Medicare Drug Price Negotiation Program. This proposed rule also includes proposals to codify existing subregulatory guidance in the Part C and Part D programs.","document_number":"2024-27939","html_url":"https://www.federalregister.gov/documents/2024/12/10/2024-27939/medicare-and-medicaid-programs-contract-year-2026-policy-and-technical-changes-to-the-medicare","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-12-10/pdf/2024-27939.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-27939.pdf?1732656194","publication_date":"2024-12-10","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"},{"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":"are being used by enrollees, and how the provision of these benefits can be <span class=\"match\">improved</span>. These most recent efforts began with a request for information (RFI) published in in the August 1, 2022, \n Federal Register \n (87 FR 46918) that solicited <span class=\"match\">feedback</span> on ways to strengthen the MA program, including ways to <span class=\"match\">improve</span> the transparency of supplemental benefits. We received thousands of responses to these requests, and we have used this information to inform our efforts to <span class=\"match\">improve</span> how benefits are administrated within the MA program. A few commenters to the"},{"title":"Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; and Quality Reporting Programs; Including the Hospital Outpatient Quality Reporting Program and Ambulatory Surgical Center Quality Program; Request for Information on Strengthening the Standardization and Comparability of Hospital Price Transparency (HPT) Data; Prior Authorization; Accrediting Organization (AO) Deeming for Emergency Medical Treatment and Labor Act (EMTALA); and Notices of Closure of Teaching Hospitals and Opportunities To Apply for Available Slots","type":"Proposed Rule","abstract":"This proposed rule would revise the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) payment system for calendar year 2027 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 proposed rule would update and refine the requirements for the Hospital Outpatient Quality Reporting Program and the Ambulatory Surgical Center Quality Reporting Program. There are no changes to the Rural Emergency Hospital Quality Reporting Program. We propose to expand the prior authorization requirement to include additional Botulinum Toxin Injection services. We also propose to implement certain provisions of the Consolidated Appropriations Act, 2026, for off-campus outpatient departments of a provider. In addition, this proposed rule announces notices of closure of teaching hospitals and opportunities to apply for available slots. This rule also requests information regarding potential approaches to improve comparability and standardization, particularly for complex contracting methodologies, of the HPT information reported in machine- readable files and consumer-friendly displays. We propose hospital AOs with deeming authority to assess compliance with certain Emergency Medical Treatment and Labor Act (EMTALA) administrative requirements during accreditation and reaccreditation surveys. Finally, we are soliciting comments on a potential separate payment under the Inpatient Prospective Payment System (IPPS) for domestic procurement of personal protective equipment and essential medicines.","document_number":"2026-13656","html_url":"https://www.federalregister.gov/documents/2026/07/07/2026-13656/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-payment","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-07/pdf/2026-13656.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-13656.pdf?1782996328","publication_date":"2026-07-07","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":"that is unresponsive to, or ineligible for, currently available treatments that can only be treated with the LINK\n TM \n External Fixator and <span class=\"match\">provide</span> corresponding supporting evidence; (2) <span class=\"match\">provide</span> sufficient evidence of the LINK\n TM \n External Fixator's effect on recovery time, adverse events, pain, or any other clinical outcomes; or (3) submit evidence that the LINK\n TM \n External Fixator substantially <span class=\"match\">improves</span> the diagnosis or treatment of an illness when compared to other available treatments.\n \n \n First, the applicant asserted that the LINK\n TM"},{"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":"Proposed Rule","abstract":"This major proposed 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":"2025-13271","html_url":"https://www.federalregister.gov/documents/2025/07/16/2025-13271/medicare-and-medicaid-programs-cy-2026-payment-policies-under-the-physician-fee-schedule-and-other","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-07-16/pdf/2025-13271.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-13271.pdf?1752524111","publication_date":"2025-07-16","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":"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":"methodology, and to continue to consider alternatives that <span class=\"match\">improve</span> the stability and accuracy of our overall PE methodology. We reiterate our discussion summarizing the responses to previous years' RFIs in each of the CY 2023 and CY 2024 final rules (refer to 87 FR 69429 through 69432 and 88 FR 78841 to 78843). We also requested general information from the public on ways that CMS may continue work to <span class=\"match\">improve</span> the stability and predictability of any future updates. Specifically, we \n \n requested <span class=\"match\">feedback</span> from interested parties regarding scheduled, recurring"},{"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":"evidence-based innovations that <span class=\"match\">improve</span> cardiovascular care. Providers believe that the current APC assignment <span class=\"match\">provides</span> adequate reimbursement that appropriately reflects the clinical complexity and resource requirements to <span class=\"match\">provide</span> these services.\n \n \n Many commenters believe that these services are underutilized, in part due to historical underpayment and billing restrictions that they encountered in the past and expressed concern about the continued challenges with making changes to billing patterns. Commenters requested that CMS <span class=\"match\">provide</span> a specific timeline"},{"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":"Implementing high-quality primary care: Rebuilding the foundation of health care. Washington, DC: The National Academies Press. \n https://doi.org/10.17226/25983 \n .\n \n \n \n \n 26 \n  Team-based approaches to care can achieve <span class=\"match\">improved</span> provider and care team satisfaction, <span class=\"match\">improved</span> team communication, <span class=\"match\">improved</span> patient safety, and <span class=\"match\">improved</span> patient and family engagement in care. Coleman, M. Dexter. D., &amp; Nankivill, N. (2015, August). Factors affecting physician satisfaction and Wisconsin Medical Society strategies to drive change. Wisconsin Medical Journal"},{"title":"Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2025; Updating Section 1332 Waiver Public Notice Procedures; Medicaid; Consumer Operated and Oriented Plan (CO-OP) Program; and Basic Health Program","type":"Rule","abstract":"This final rule includes payment parameters and provisions related to the HHS-operated risk adjustment program, as well as 2025 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 requirements related to the auto re-enrollment hierarchy; essential health benefits; failure to file Federal income taxes to reconcile advance payments of the premium tax credit (APTC); non- standardized plan option limits in the FFEs and SBE-FPs and a related exceptions process; standardized plan options in the FFEs and SBE-FPs; special enrollment periods (SEPs); direct enrollment (DE) entities supporting Exchange applications and enrollments; the Insurance Affordability Program enrollment eligibility verification process; requirements for agents, brokers, web-brokers, and DE entities assisting Exchange consumers; network adequacy; public notice procedures for section 1332 waivers; prescription drug benefits; updates to the Consumer Operated and Oriented Plan (CO-OP) Program; and State flexibility on the effective date of coverage in the Basic Health Program (BHP).","document_number":"2024-07274","html_url":"https://www.federalregister.gov/documents/2024/04/15/2024-07274/patient-protection-and-affordable-care-act-hhs-notice-of-benefit-and-payment-parameters-for-2025","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-04-15/pdf/2024-07274.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-07274.pdf?1712351231","publication_date":"2024-04-15","agencies":[{"raw_name":"DEPARTMENT OF THE TREASURY","name":"Treasury Department","id":497,"url":"https://www.federalregister.gov/agencies/treasury-department","json_url":"https://www.federalregister.gov/api/v1/agencies/497","parent_id":null,"slug":"treasury-department"},{"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":"plans for certain <span class=\"match\">audit</span> observations aligns with previously established regulations requiring corrective action plans for <span class=\"match\">audit</span> findings for risk adjustment <span class=\"match\">audits</span>. Issuers can find more information about corrective action plans and the general high-cost risk pool <span class=\"match\">audit</span> process by reviewing past <span class=\"match\">audit</span> reports \n 118 \n \n and high-cost risk pool <span class=\"match\">audit</span> summary reports.\n 119 \n \n An issuer selected for a high-cost risk pool <span class=\"match\">audit</span> will also have the opportunity to ask questions during the entrance conference \n 120 \n \n and throughout the <span class=\"match\">audit</span> process. Additionally"},{"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":"Proposed Rule","abstract":"This major proposed 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, and proposing 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.","document_number":"2024-14828","html_url":"https://www.federalregister.gov/documents/2024/07/31/2024-14828/medicare-and-medicaid-programs-cy-2025-payment-policies-under-the-physician-fee-schedule-and-other","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-07-31/pdf/2024-14828.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-14828.pdf?1720642528","publication_date":"2024-07-31","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":"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":"community-based crisis stabilization, including 24/7 receiving and short-term stabilization centers, that <span class=\"match\">provide</span> immediate access to voluntary and/or involuntary care, without the need for a referral. Regarding such crisis stabilization units, we are interested in <span class=\"match\">feedback</span> on the following questions, as well as any other relevant <span class=\"match\">feedback</span>: \n ++ What kind of services do crisis stabilization units <span class=\"match\">provide</span>? Do crisis stabilization units <span class=\"match\">provide</span> services similar to those described by the psychotherapy for crisis codes (CPT codes 90839 and 90840)? \n"},{"title":"Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs, Including the Hospital Inpatient Quality Reporting Program; Health and Safety Standards for Obstetrical Services in Hospitals and Critical Access Hospitals; Prior Authorization; Requests for Information; Medicaid and CHIP Continuous Eligibility; Medicaid Clinic Services Four Walls Exceptions; Individuals Currently or Formerly in Custody of Penal Authorities; Revision to Medicare Special Enrollment Period for Formerly Incarcerated Individuals; and All-Inclusive Rate Add-On Payment for High-Cost Drugs Provided by Indian Health Service and Tribal Facilities","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 2025 based on our continuing experience with these systems. We 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 system. Also, this final rule updates the requirements for the Hospital Outpatient Quality Reporting Program, Rural Emergency Hospital Quality Reporting Program, Ambulatory Surgical Center Quality Reporting Program, and Hospital Inpatient Quality Reporting Program. We also summarize information received in response to a Request for Information on potential modifications to the Safety of Care measure group in the Overall Hospital Quality Star Rating methodology. In this final rule, we are also finalizing our proposal to narrow the description of \"custody\" in the Medicare payment exclusion rule and to revise the special enrollment period criteria for formerly incarcerated individuals. We are also finalizing our Medicaid and Children's Health Insurance Program (CHIP) continuous eligibility provisions. We are also finalizing the proposal to reduce the review timeframe for standard prior authorization requests for certain covered outpatient department services paid under the OPPS from 10-business days to 7-calendar days. Further, this rule finalizes updates to the Conditions of Participation (CoPs) for hospitals and critical access hospitals (CAHs) in an effort to advance the health and safety of pregnant, birthing, and postpartum women. This rule also finalizes our proposed policy to separately pay Indian Health Service (IHS) and Tribal hospitals for high-cost drugs furnished in hospital outpatient departments through an add-on payment in addition to the all-inclusive rate (AIR) under the authorities used to calculate the AIR starting January 1, 2025. Finally, we are finalizing exceptions to the Medicaid clinic services four walls requirement for IHS and Tribal clinics, and, at state option, for behavioral health clinics and clinics located in rural areas.","document_number":"2024-25521","html_url":"https://www.federalregister.gov/documents/2024/11/27/2024-25521/medicare-and-medicaid-programs-hospital-outpatient-prospective-payment-and-ambulatory-surgical","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-11-27/pdf/2024-25521.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-25521.pdf?1730492130","publication_date":"2024-11-27","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":"payment could <span class=\"match\">provide</span> an opportunity to <span class=\"match\">improve</span> payment accuracy for separately payable diagnostic radiopharmaceuticals by applying an established methodology that has already been successfully implemented under the OPPS for other separately payable drugs and biologicals, as well as therapeutic radiopharmaceuticals. Because the per day cost calculations determine whether a diagnostic radiopharmaceutical qualifies for separate payment, using the most accurate pricing information is paramount. The use of ASP information could <span class=\"match\">provide</span> an opportunity"},{"title":"Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Overall Hospital Quality Star Ratings; and Hospital Price Transparency","type":"Proposed Rule","abstract":"This proposed rule would revise 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. This proposed rule would also update and refine 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. This rule also contains requests for information on measure concepts regarding Well-Being and Nutrition for consideration in future years for all three programs (OQR, REHQR, and ASCQR; expanding the method to control for unnecessary increases in the volume of covered OPD services to on- campus clinic visits; software as a service; and adjusting payment under the OPPS for services predominately performed in the ambulatory surgical center or physician office settings.","document_number":"2025-13360","html_url":"https://www.federalregister.gov/documents/2025/07/17/2025-13360/medicare-and-medicaid-programs-hospital-outpatient-prospective-payment-and-ambulatory-surgical","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-07-17/pdf/2025-13360.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-13360.pdf?1752610509","publication_date":"2025-07-17","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":"whether the aprevo® Cervical ACDF System meets the device category criterion at § 419.66(c)(1). \n The second criterion for establishing a device category, at § 419.66(c)(2), <span class=\"match\">provides</span> that CMS determines either of the following: (i) that a device to be included in the category has demonstrated that it will substantially <span class=\"match\">improve</span> the diagnosis or treatment of an illness or injury or <span class=\"match\">improve</span> the functioning of a malformed body part compared to the benefits of a device or devices in a previously established category or other available treatment; or (ii) for"},{"title":"Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Payment for Intensive Outpatient Services in Hospital Outpatient Departments, Community Mental Health Centers, Rural Health Clinics, Federally Qualified Health Centers, and Opioid Treatment Programs; Hospital Price Transparency; Changes to Community Mental Health Centers Conditions of Participation, Changes to the Inpatient Prospective Payment System Medicare Code Editor; Rural Emergency Hospital Conditions of Participation Technical Correction","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 2024 based on our continuing experience with these systems. In this final rule, we 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 system. Also, this final rule updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program, the ASC Quality Reporting (ASCQR) Program, and the Rural Emergency Hospital Quality Reporting (REHQR) Program. In this final rule, we are also establishing a payment for certain intensive outpatient services under Medicare, beginning January 1, 2024. In addition, this final rule updates and refines requirements for hospitals to make public their standard charge information and enforcement of hospital price transparency. We are finalizing changes to the community mental health center (CMHC) Conditions of Participation (CoPs) to provide requirements for furnishing intensive outpatient (IOP) services, and we are finalizing the proposed personnel qualifications for mental health counselors (MHCs) and marriage and family therapists (MFTs). Additionally, we are finalizing the removal of discussion of the inpatient prospective payment system (IPPS) Medicare Code Editor (MCE) from the annual IPPS rulemakings, beginning with the fiscal year (FY) 2025 rulemaking. Finally, we are finalizing a technical correction to the Rural Emergency Hospital (REH) CoPs under the standard for the designation and certification of REHs.","document_number":"2023-24293","html_url":"https://www.federalregister.gov/documents/2023/11/22/2023-24293/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-payment","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-11-22/pdf/2023-24293.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-24293.pdf?1698959177","publication_date":"2023-11-22","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":"devices have not been described by existing device categories or those previously in effect. \n \n The second criterion for establishing a device category, at § 419.66(c)(2), <span class=\"match\">provides</span> that CMS determines either of the following: (i) that a device is included in the category that has demonstrated that it will substantially <span class=\"match\">improve</span> the diagnosis or treatment of an illness or injury or <span class=\"match\">improve</span> the functioning of a malformed body party compared to the benefits of a device or devices in a previously established category or other available treatment; or (ii) for"},{"title":"Nondiscrimination on the Basis of Disability in Programs or Activities Receiving Federal Financial Assistance","type":"Rule","abstract":"The Department of Health and Human Services (HHS or the Department) is committed to protecting the civil rights of individuals with disabilities under section 504 of the Rehabilitation Act of 1973 (section 504). To implement the prohibition of discrimination on the basis of disability, the Department is making a number of revisions to update and amend its section 504 regulation.","document_number":"2024-09237","html_url":"https://www.federalregister.gov/documents/2024/05/09/2024-09237/nondiscrimination-on-the-basis-of-disability-in-programs-or-activities-receiving-federal-financial","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-05-09/pdf/2024-09237.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-09237.pdf?1714567521","publication_date":"2024-05-09","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"}],"excerpts":"based prohibition against discrimination articulated in § 84.56(a). \n \n Failure to <span class=\"match\">provide</span> comprehensive information about and access to all forms of contraception and failure to <span class=\"match\">provide</span> comprehensive information and access to assistive reproduction technology and other treatments related to infertility to qualified persons with disabilities by a recipient that <span class=\"match\">provides</span> such treatment would likely violate § 84.56(a) or (b)(2) if the recipient <span class=\"match\">provides</span> or would <span class=\"match\">provide</span> the same information and access to an individual without a disability. Denial or"},{"title":"Medicare and Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Advantage; Medicare and Medicaid Provider and Supplier Enrollment Policies; and Basic Health 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; payment for dental services inextricably linked to specific covered medical services; 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 certain Medicare and Medicaid provider and supplier enrollment policies, electronic prescribing for controlled substances for a covered Part D drug under a prescription drug plan or an MA-PD plan under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act); updates to the Ambulance Fee Schedule regulations and the Medicare Ground Ambulance Data Collection System; codification of the Inflation Reduction Act and Consolidated Appropriations Act, 2023 provisions; expansion of the diabetes screening and diabetes definitions; pulmonary rehabilitation, cardiac rehabilitation and intensive cardiac rehabilitation expansion of supervising practitioners; appropriate use criteria for advanced diagnostic imaging; early release of Medicare Advantage risk adjustment data; a social determinants of health risk assessment in the annual wellness visit and Basic Health Program.","document_number":"2023-24184","html_url":"https://www.federalregister.gov/documents/2023/11/16/2023-24184/medicare-and-medicaid-programs-cy-2024-payment-policies-under-the-physician-fee-schedule-and-other","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-11-16/pdf/2023-24184.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-24184.pdf?1698956273","publication_date":"2023-11-16","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":"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":"available. These commenters stated that reliance on the PPIS updates may not <span class=\"match\">improve</span> the accuracy and stability of the PE methodology because of the survey design, possible implementation challenges, and a possible lack of transparency or granularity in resulting datasets.\n \n \n Response: \n We thank commenters for their <span class=\"match\">feedback</span>. We believe it remains important to reflect on the challenges with our current methodology, and to continue to consider alternatives that <span class=\"match\">improve</span> the stability and accuracy of our overall PE methodology. We reiterate our discussion"},{"title":"Discrimination on the Basis of Disability in Health and Human Service Programs or Activities","type":"Proposed Rule","abstract":"The Department of Health and Human Services (HHS or the Department) is committed to protecting the civil rights of individuals with disabilities under section 504 of the Rehabilitation Act of 1973 (section 504). To implement the prohibition of discrimination on the basis of disability, the Department proposes to update and amend its section 504 regulation. The proposed rule would add new provisions that clarify existing requirements under section 504 prohibiting recipients of financial assistance from the Department (recipients) from discriminating on the basis of disability in their programs and activities, including in health care, child welfare, and other human services. The proposed rule includes new requirements prohibiting discrimination in the areas of medical treatment; the use of value assessments; web, mobile, and kiosk accessibility; and requirements for accessible medical equipment, so that persons with disabilities have an opportunity to participate in or benefit from health care programs and activities that is equal to the opportunity afforded others. It also adds a section on child welfare to expand on and clarify the obligation to provide nondiscriminatory child welfare services. The proposed rule would also update the definition of disability and other provisions to ensure consistency with statutory amendments to the Rehabilitation Act, enactment of the Americans with Disabilities Act and the Americans with Disabilities Amendments Act of 2008, the Affordable Care Act, as well as Supreme Court and other significant court cases. It also further clarifies the obligation to provide services in the most integrated setting. Finally, the proposed rule would make other clarifying edits, including updating outdated terminology and references.","document_number":"2023-19149","html_url":"https://www.federalregister.gov/documents/2023/09/14/2023-19149/discrimination-on-the-basis-of-disability-in-health-and-human-service-programs-or-activities","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-09-14/pdf/2023-19149.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-19149.pdf?1694440872","publication_date":"2023-09-14","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"}],"excerpts":" U.S. Dep't of Health &amp; Hum. Servs., Off. for Civil Rts., OCR <span class=\"match\">Provides</span> Technical Assistance to Ensure Crisis Standards of Care Protect Against Age and Disability Discrimination (Jan. 14, 2021), \n https://www.hhs.gov/about/news/2021/01/14/ocr-<span class=\"match\">provides</span>-technical-assistance-ensure-crisis-standards-of-care-protect-against-age-disability-discrimination.html. \n \n \n \n \n 86 \n  \n See id. \n \n \n \n \n 87 \n  \n See \n U.S. Dep't of Health &amp; Hum. Servs., Off. for Civil Rts., OCR <span class=\"match\">Provides</span> Technical Assistance to the State of Arizona to Ensure Crisis Standards"},{"title":"Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases","type":"Rule","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule revising the requirements concerning current good manufacturing practice (CGMP), postmarketing safety reporting, and labeling that apply to certain medical gases. This final rule also establishes regulations regarding certification of designated medical gases. This final rule satisfies the medical gas rulemaking requirements of the Consolidated Appropriations Act, 2017.","document_number":"2024-13190","html_url":"https://www.federalregister.gov/documents/2024/06/18/2024-13190/current-good-manufacturing-practice-certification-postmarketing-safety-reporting-and-labeling","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-06-18/pdf/2024-13190.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-13190.pdf?1718628314","publication_date":"2024-06-18","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":"best help to address the unique characteristics of medical gases when implemented collectively, each provision independently <span class=\"match\">improves</span> the clarity of the regulations and requirements applicable to medical gases. In the event of a stay or invalidation of any major provision(s), those that remain in effect would continue to function sensibly \n 2 \n \n to advance the statutory requirements applicable to medical gases and <span class=\"match\">provide</span> useful, clear standards for firms to meet their existing statutory obligations. For example, invalidation of the major provisions"},{"title":"Federal Independent Dispute Resolution Operations","type":"Proposed Rule","abstract":"This document sets forth proposed rules related to certain provisions of the No Surprises Act regarding the Federal independent dispute resolution (IDR) process, which was established as part of the Consolidated Appropriations Act, 2021 (CAA). These proposed rules would set forth new requirements relating to the disclosure of information that group health plans and health insurance issuers offering group or individual health insurance coverage must include along with the initial payment or notice of denial of payment for certain items and services subject to the surprise billing protections in the No Surprises Act. These proposed rules would also require plans and issuers to communicate information by using claim adjustment reason codes (CARCs) and remittance advice remark codes (RARCs), as specified in guidance, when providing any paper or electronic remittance advice to an entity that does not have a contractual relationship with the plan or issuer. This document also proposes to amend certain requirements related to the open negotiation period preceding the Federal IDR process, the initiation of the Federal IDR process, the Federal IDR dispute eligibility review, and the payment and collection of administrative fees and certified IDR entity fees. This document also proposes to define bundled payment arrangements, amend requirements related to batched items and services, and amend the rules for extensions of timeframes due to extenuating circumstances. Additionally, this document proposes to require plans and issuers to register in the Federal IDR portal. In accordance with Federal law, a summary of these rules may be found at https://www.regulations.gov/.","document_number":"2023-23716","html_url":"https://www.federalregister.gov/documents/2023/11/03/2023-23716/federal-independent-dispute-resolution-operations","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-11-03/pdf/2023-23716.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-23716.pdf?1698437724","publication_date":"2023-11-03","agencies":[{"raw_name":"OFFICE OF PERSONNEL MANAGEMENT","name":"Personnel Management Office","id":406,"url":"https://www.federalregister.gov/agencies/personnel-management-office","json_url":"https://www.federalregister.gov/api/v1/agencies/406","parent_id":null,"slug":"personnel-management-office"},{"raw_name":"DEPARTMENT OF THE TREASURY","name":"Treasury Department","id":497,"url":"https://www.federalregister.gov/agencies/treasury-department","json_url":"https://www.federalregister.gov/api/v1/agencies/497","parent_id":null,"slug":"treasury-department"},{"raw_name":"Internal Revenue Service","name":"Internal Revenue Service","id":254,"url":"https://www.federalregister.gov/agencies/internal-revenue-service","json_url":"https://www.federalregister.gov/api/v1/agencies/254","parent_id":497,"slug":"internal-revenue-service"},{"raw_name":"DEPARTMENT OF LABOR","name":"Labor Department","id":271,"url":"https://www.federalregister.gov/agencies/labor-department","json_url":"https://www.federalregister.gov/api/v1/agencies/271","parent_id":null,"slug":"labor-department"},{"raw_name":"Employee Benefits Security Administration","name":"Employee Benefits Security Administration","id":131,"url":"https://www.federalregister.gov/agencies/employee-benefits-security-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/131","parent_id":271,"slug":"employee-benefits-security-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"},{"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":" \n 81 \n \n explains that if a physician performs bilateral <span class=\"match\">mammography</span>, the provider shall report (or for the purpose of the Federal IDR process, the provider shall bill) Current Procedural Terminology (CPT) code 77066 (\n Diagnostic <span class=\"match\">mammography</span> . . . bilateral \n ). The provider should not submit CPT code 77065 (\n Diagnostic <span class=\"match\">mammography</span> . . . unilateral \n ) with 2 UOS or CPT code 77065 LT (\n unilateral left breast <span class=\"match\">mammography</span> \n ) plus CPT code 77065 RT (\n unilateral right breast <span class=\"match\">mammography</span> \n ). Under this example, the provider performed multiple services"},{"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":"devices are those devices for which general controls by themselves are insufficient to <span class=\"match\">provide</span> reasonable assurance of safety and effectiveness, but for which there is sufficient information to establish special controls to <span class=\"match\">provide</span> such assurance, including the promulgation of performance standards, post-market surveillance, patient registries, development and dissemination of guidelines, recommendations, and other appropriate actions the Agency deems necessary to <span class=\"match\">provide</span> such assurance (section 513(a)(1)(B) of the FD&amp;C Act). \n Class III devices are"}]}