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| Tipoffs: Public Comments on Proposed Federal Rules Newsletter for 2026-07-04 ( 322 items ) |
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5 U.S. Senators Call for Withdrawal of Basel III Endgame Bank Capital Proposals (10)
WASHINGTON, July 3 -- Five U.S. senators have urged the Federal Reserve Board, the Office of the Comptroller of the Currency, and the Federal Deposit Insurance Corp. to withdraw three bank capital proposals issued in March 2026, including the Basel III Endgame package. The senators, speaking from Washington, D.C., argue that the proposals would primarily benefit the largest Wall Street banks by reducing loss-absorbing capital requirements by 6% to 15%, undermining the resilience of the banking system amid economic uncertainties.
The senators e more ST
A Helping Hand Raises Concerns Over Medicaid Community Engagement Rule Impact on Opioid Treatment Access (10)
WASHINGTON, July 3 -- A Helping Hand LLC, a Maryland-based licensed Opioid Treatment Program, has submitted a public comment letter to the Centers for Medicare & Medicaid Services addressing issues with the Medicaid Program's Community Engagement Requirement Interim Final Rule. The organization highlighted that the rule's current interpretation may reduce access to critical opioid use disorder treatments for Medicaid beneficiaries.
The letter emphasizes that the rule excludes patients receiving treatment at licensed for-profit Opioid Treatment more ST
A.J. Drexel Autism Institute Postdoctoral Research Fellow Yu Urges Withdrawal of OMB Proposed Rule on Federal Research Funding (10)
WASHINGTON, July 3 -- Justin Yu, postdoctoral research fellow at the A.J. Drexel Autism Institute, Philadelphia, Pennsylvania, submitted a public comment letter to the Office of Management and Budget (OMB) opposing the proposed revision of 2 C.F.R. Part 200 concerning federal financial assistance. The letter, sent on June 26, 2026, raises concerns that the rule, slated for an October 1, 2026 effective date, endangers the integrity and inclusivity of federally funded scientific research.
Yu's letter highlights multiple provisions in the propose more ST
AARP Urges CMS to Enhance Prior Authorization Rules for Drug Access (10)
WASHINGTON, July 3 -- AARP, an advocacy organization representing 125 million Americans aged 50 and older, has endorsed the Centers for Medicare & Medicaid Services' proposed rule aimed at improving interoperability standards and prior authorization processes for prescription drugs. In a public comment letter submitted to the U.S. Department of Health and Human Services, AARP expressed support for measures designed to reduce delays and denials that often hinder timely access to necessary medications.
The advocacy group emphasized the critical more ST
AbbVie Supports Centers for Medicare & Medicaid Services Proposed Rule to Streamline Prior Authorization for Prescription Drugs (10)
WASHINGTON, July 3 -- AbbVie Inc., a biopharmaceutical company in North Chicago, Illinois, has submitted a public comment letter to the Centers for Medicare & Medicaid Services addressing the agency's proposed rule on interoperability standards and prior authorization for drugs. The proposal targets Medicare Advantage organizations, Medicaid managed care plans, State Medicaid and CHIP Agencies, CHIP managed care entities, and issuers of qualified health plans on the federally-facilitated exchanges. AbbVie applauds CMS for its efforts to enhance more ST
Academy of Managed Care Pharmacy Urges Extended Timeline for Centers for Medicare & Medicaid Services Prior Authorization Rule (10)
WASHINGTON, July 3 -- The Academy of Managed Care Pharmacy, Alexandria, Virginia, has submitted a public comment letter to the Centers for Medicare & Medicaid Services regarding the agency's Interoperability Standards and Prior Authorization for Drugs Proposed Rule. AMCP emphasizes the importance of prior authorization as a clinical management tool to ensure appropriate medication use, patient safety, and cost-effective care, while expressing concerns about the feasibility of the proposed implementation timeline and requesting clarifications to more ST
Accountable for Health Highlights Challenges in Hospital Admission Notifications to Centers for Medicare & Medicaid Services and Office of the National Coordinator (10)
WASHINGTON, July 3 -- Accountable for Health, a national advocacy and policy organization, has submitted a public comment letter to the U.S. Department of Health and Human Services Centers for Medicare & Medicaid Services and the Office of the National Coordinator for Health Information Technology. The letter focuses on challenges faced by accountable care organizations in receiving timely and complete admission, discharge, and transfer notifications from hospitals under current Center for Medicare & Medicaid Services conditions of participatio more ST
Advarra Provides Comments on Food and Drug Administration's Draft Guidance for Responding to Drug CGMP Inspection Observations (10)
WASHINGTON, July 3 -- Advarra Inc., Columbia, Maryland, submitted a public comment letter to the Food and Drug Administration regarding the agency's draft guidance on responding to FDA Form 483 observations issued at the conclusion of drug current good manufacturing practice inspections. Advarra offered a comprehensive review and several recommendations for enhancing the clarity and effectiveness of the guidance issued in March 2026.
Advarra suggested that the guidance include additional footnotes to clarify circumstances under which correctiv more ST
ADVION Warns Centers for Medicare & Medicaid Services That Prior Authorization Rules Threaten Urgent Nursing Home Lab Testing (10)
WASHINGTON, July 3 -- ADVION, a national organization representing health information technology companies serving long term and post-acute care providers, submitted a public comment letter to the Centers for Medicare & Medicaid Services addressing the agency's proposed rules concerning prior authorization requirements for laboratory tests and durable medical equipment. ADVION emphasized the challenges that prior authorization poses specifically for mobile clinical laboratory services that provide essential diagnostic testing to nursing home re more ST
AI-Enabled Platform Proposed to Expand Access and Efficiency in Early-Phase Oncology Trials (10)
WASHINGTON, July 3 -- ActioPath Technologies, Seattle, Washington state, has submitted a public comment letter to the U.S. Food and Drug Administration regarding the agency's AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. The letter outlines a recommendation that artificial intelligence be evaluated as reusable clinical development infrastructure that persists across studies at research sites and among sponsors, rather than stand-alone tools rebuilt for each new trial. This approach aims to address critical accessibility more ST
AIDS Institute Urges Centers for Medicare & Medicaid Services to Enhance Prior Authorization Standards for Prescription Drugs (10)
WASHINGTON, July 3 -- The AIDS Institute, Tarrytown, New York, has submitted a public comment letter to the Centers for Medicare and Medicaid Services regarding the agency's proposed rule on Interoperability Standards and Prior Authorization for Drugs. The organization emphasized the importance of streamlining prior authorization procedures to improve access to medications for patients with chronic illnesses such as HIV and hepatitis.
The letter highlights the burdensome nature of prior authorization as a utilization management tool, intended more ST
Airlines for America Seeks Changes to Federal Aviation Administration Flightcrew Duty Reporting Requirements (10)
WASHINGTON, July 3 -- Airlines for America, a trade association representing major U.S. air carriers, has submitted a public comment letter to the Federal Aviation Administration regarding the agency's information collection activities related to flight and duty limitations and rest requirements for flightcrew members. The comments address the FAA's renewal request for approval under the Paperwork Reduction Act of 1995 concerning three types of data collections: reports of flight time limitation and flight duty period extensions, submissions of more ST
Airports Council International Urges Environmental Protection Agency for Practical PFAS Disposal Guidance and Federal Coordination (10)
WASHINGTON, July 3 -- Airports Council International - North America, representing over 300 U.S. airports, submitted a public comment letter to the U.S. Environmental Protection Agency regarding the agency's Interim PFAS Destruction and Disposal Guidance. ACI-NA's members are responsible for airports that have historically used aqueous film forming foam containing per- and polyfluoroalkyl substances as mandated by the Federal Aviation Administration for firefighting purposes. The letter highlights challenges airports face in managing PFAS conta more ST
Alexion AstraZeneca Rare Disease Urges Food and Drug Administration to Advance AI Use in Rare Disease Clinical Trials (10)
WASHINGTON, July 3 -- Alexion AstraZeneca Rare Disease, Boston, Massachusetts, offered extensive input to the Food and Drug Administration regarding the agency's AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. The public comment letter emphasized how artificial intelligence could fundamentally improve trial design and execution in rare diseases, addressing unique challenges such as small patient populations, clinical heterogeneity, and limited natural history data.
The group highlighted that rare disease patients experien more ST
Alliant Energy Urges Site-Specific Approach in Environmental Protection Agency's Coal Combustion Residual Regulations (10)
WASHINGTON, July 3 -- Alliant Energy Corp., Madison, Wisconsin, has submitted a public comment letter to the U.S. Environmental Protection Agency regarding the agency's proposal to revise existing Coal Combustion Residual regulations. In its letter, Alliant Energy, representing its utility subsidiaries Interstate Power and Light Company and Wisconsin Power and Light Company, both serving customers primarily in Iowa and Wisconsin, advocates for a flexible regulatory framework based on site-specific data and real-world conditions.
The energy com more ST
ALS Network Endorses Food and Drug Administration AI Pilot Program With Calls for Transparency and Patient Safety (10)
WASHINGTON, July 3 -- ALS Network, a California-based advocacy group dedicated to people with amyotrophic lateral sclerosis and their families, has expressed support for the U.S. Food and Drug Administration's pilot program on AI-Enabled Optimization of Early-Phase Clinical Trials. The organization submitted a public comment letter to the FDA highlighting the potential benefits of artificial intelligence in improving clinical trial efficiency, patient selection, and data analysis, while emphasizing the need for maintaining rigorous scientific s more ST
ALS United Urges Centers for Medicare & Medicaid Services to Reform Prior Authorization Rules for Timely Laboratory Testing in ALS Care (10)
WASHINGTON, July 3 -- ALS United, a nationwide partnership of independent nonprofit organizations, has submitted a public comment letter to the Centers for Medicare & Medicaid Services regarding the agency's proposed rule on prior authorization and access to laboratory testing under Medicare and Medicaid programs. The organization emphasizes the importance of timely laboratory testing for individuals living with amyotrophic lateral sclerosis, a rapidly progressing neurodegenerative disease.
ALS United highlights that laboratory testing, includ more ST
ALS United Urges Food and Drug Administration to Include ALS in AI-Enabled Optimization of Early Clinical Trials Pilot (10)
WASHINGTON, July 3 -- ALS United, a nationwide partnership of nonprofit organizations dedicated to improving research, care, and advocacy for amyotrophic lateral sclerosis, has submitted a public comment letter to the U.S. Food and Drug Administration on the agency's AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. Headquartered in Detroit, Michigan, ALS United emphasized the importance of including ALS and other rapidly progressive neurodegenerative diseases in the pilot given the critical need for faster, more efficient d more ST
Altis Labs Advocates for AI-Derived Endpoints in Early-Phase Oncology Trials to Enhance Drug Development Efficiency (10)
WASHINGTON, July 3 -- Altis Labs, a Boston, Massachusetts-based oncology-focused computational imaging company, submitted a public comment letter to the U.S. Food and Drug Administration regarding the AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. The company offered detailed recommendations to enhance the pilot's design and execution by integrating artificial intelligence-derived efficacy endpoints in early-phase cancer clinical trials, particularly focusing on solid tumors such as non-small cell lung cancer.
Altis Labs more ST
Alzheimer's Association and Alzheimer's Impact Movement Advocate for Clear Prior Authorization Rules for Alzheimer's Drugs (10)
WASHINGTON, July 3 -- The Alzheimer's Association and the Alzheimer's Impact Movement, Chicago, Illinois, have submitted a public comment letter to the Centers for Medicare & Medicaid Services addressing the agency's Proposed Rule on interoperability standards and prior authorization for drugs. The organizations expressed support for the efforts to streamline prior authorization processes for Medicare Advantage, Medicaid, CHIP, and Qualified Health Plans, while emphasizing protections for patients with Alzheimer's disease.
In their letter, the more ST
Ameren Urges Environmental Protection Agency to Clarify Definitions to Facilitate Power Plant Construction and Meet Growing Energy Demand (10)
WASHINGTON, July 3 -- Ameren Corp., St. Louis, Missouri, submitted a public comment letter to the U.S. Environmental Protection Agency regarding the agency's proposed rule to redefine the term "begin actual construction" under the New Source Review preconstruction permitting program. The proposal, published on May 13, 2026, seeks to remove impediments to construction that do not impact air quality, but Ameren urges the EPA to further refine definitions related to construction activities and pollutant-emitting components to provide clarity and f more ST
American Academy of Dermatology Urges CMS to Reform Prior Authorization and Step Therapy Policies (10)
WASHINGTON, July 3 -- The American Academy of Dermatology Association, Schaumburg, Illinois, has submitted a public comment letter to the Centers for Medicare & Medicaid Services addressing the 2026 Interoperability Standards and Prior Authorization for Drugs proposed rule. Representing over 18,000 dermatologists nationwide, the Academy highlights the burdens imposed by prior authorization and step therapy protocols on physicians and patients.
The Academy advocates for standardizing prior authorization time frames, recommending that expedited more ST
American Academy of Pediatrics Urges Uniform Prior Authorization Standards to Improve Child Healthcare Access (10)
WASHINGTON, July 3 -- The American Academy of Pediatrics, Itasca, Illinois, has submitted a public comment letter to the U.S. Department of Health and Human Services Centers for Medicare & Medicaid Services addressing the agency's proposed rulemaking on interoperability standards and prior authorization processes for prescription drugs under Medicare and Medicaid programs. The AAP, representing over 67,000 pediatricians and pediatric specialists, emphasizes the need for standardized, efficient prior authorization procedures to reduce barriers t more ST
American Academy of Sleep Medicine Urges Centers for Medicare & Medicaid Services to Enhance Prior Authorization Processes for Sleep Care (10)
WASHINGTON, July 3 -- The American Academy of Sleep Medicine, Darien, Illinois, has submitted a public comment letter to the Centers for Medicare & Medicaid Services urging improvements to the interoperability standards and prior authorization requirements proposed for drugs and sleep-related medical services. The organization, representing thousands of clinicians and accredited sleep centers, highlighted the significant burden that current prior authorization processes impose on providers and the potential for delays in care that affect patien more ST
American Association for Homecare Seeks Prior Authorization Reforms to Improve Access and Reduce Burden (10)
WASHINGTON, July 3 -- The American Association for Homecare, Arlington, Virginia, submitted a public comment letter to the Centers for Medicare & Medicaid Services addressing challenges with prior authorization policies for durable medical equipment, prosthetics, orthotics, and supplies. The letter highlights how current PA processes delay patient access to medically necessary home medical equipment and impose significant administrative burdens on suppliers and healthcare providers, particularly affecting patients who rely on critical therapies more ST
American Association for the Study of Liver Diseases Endorses CMS Efforts to Modernize Prior Authorization for Medications (10)
WASHINGTON, July 3 -- The American Association for the Study of Liver Diseases, Alexandria, Virginia, expressed support for the Centers for Medicare & Medicaid Services initiative to improve interoperability standards and streamline prior authorization requirements for prescription drugs under Medicare Advantage, Medicaid managed care plans, and federally facilitated health exchange plans. In a public comment letter submitted to CMS, the AASLD outlined recommendations aimed at enhancing timely patient access to specialty medications necessary f more ST
American Association of Independent Music Advocates for Reduced Copyright Registration Fees for Small Entities (10)
WASHINGTON, July 3 -- The American Association of Independent Music, New York, has submitted a public comment letter to the U.S. Copyright Office regarding alternative fee structures for copyright registration. Representing more than 600 independent record labels and music businesses across the United States, A2IM supports a reduced registration fee for small entities, emphasizing that this approach best fits the needs of independent creators and small business owners in the music industry.
A2IM highlights that most of its members operate as l more ST
American Association of Nurse Practitioners Supports Centers for Medicare & Medicaid Services Prior Authorization Proposal to Reduce Burden and Improve Access (10)
WASHINGTON, July 3 -- The American Association of Nurse Practitioners, Austin, Texas, expressed support for the Centers for Medicare & Medicaid Services proposed rule aimed at reforming prior authorization processes for drugs under Medicare Advantage Organizations, Medicaid managed care plans, State Medicaid Agencies, Children's Health Insurance Program agencies, CHIP managed care entities, and issuers of qualified health plans on federally-facilitated exchanges. The public comment letter submitted to CMS highlights the association's endorsemen more ST
American Association of Port Authorities Calls for Expanded Drone Flight Restrictions Around Seaports (10)
WASHINGTON, July 3 -- The American Association of Port Authorities, Alexandria, Virginia, has submitted a public comment letter to the U.S. Department of Transportation Federal Aviation Administration regarding the agency's proposed rulemaking on drone flight restrictions near fixed site facilities. The letter focuses on the FAA's Notice of Proposed Rulemaking for designating unmanned aircraft flight restrictions to protect critical infrastructure, specifically underscoring the unique challenges and security concerns facing strategic seaports.
more ST
American Association of Psychiatric Pharmacists Urges CMS to Address Prior Authorization Barriers in Mental Health Treatment (10)
WASHINGTON, July 3 -- The American Association of Psychiatric Pharmacists, based in Lincoln, Nebraska, has submitted a public comment letter to the U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services regarding the proposed rule on Interoperability Standards and Prior Authorization for Drugs affecting Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Children's Health Insurance Program Agencies, CHIP Managed Care Entities, and issuers of Qualified Health Plans on the Feder more ST
American Cement Association Supports Environmental Protection Agency's Proposed Clarifications to New Source Review Construction Definitions (10)
WASHINGTON, July 3 -- The American Cement Association, Washington, Pennsylvania, has expressed support for the U.S. Environmental Protection Agency's proposed rule aiming to provide regulatory clarity on when "begin actual construction" occurs under the Clean Air Act's New Source Review preconstruction permitting program. The association submitted a public comment letter emphasizing the proposal's potential to reduce regulatory uncertainty for cement manufacturers while preserving core environmental protections.
The EPA's proposed rule seeks t more ST
American College of Medical Genetics and Genomics Supports CMS Rule on Electronic Prior Authorization (10)
WASHINGTON, July 3 -- The American College of Medical Genetics and Genomics, Rockville, Maryland, has expressed support for the Centers for Medicare & Medicaid Services' proposed rule aimed at expanding electronic prior authorization requirements to all drugs covered by Medicare and Medicaid programs. In a public comment letter to CMS, the medical association highlighted the burden prior authorization processes currently place on healthcare providers and patients, particularly those dealing with rare genetic disorders.
The ACMG praised CMS's e more ST
American College of Physicians Urges Centers for Medicare & Medicaid Services to Improve Electronic Prior Authorization and Transparency Measures (10)
WASHINGTON, July 3 -- The American College of Physicians, Philadelphia, Pennsylvania, has provided a public comment letter to the U.S. Department of Health and Human Services Centers for Medicare & Medicaid Services regarding proposed regulations aimed at enhancing interoperability and prior authorization processes for drugs under Medicare and Medicaid programs. The ACP, representing 163,000 internal medicine specialists and related medical professionals, highlighted the ongoing administrative burdens that prior authorizations impose on physici more ST
American College of Rheumatology Urges Centers for Medicare and Medicaid Services to Strengthen Prior Authorization Rules for Drug Coverage (10)
WASHINGTON, July 3 -- The American College of Rheumatology, Atlanta, Georgia, has submitted a public comment letter to the Centers for Medicare and Medicaid Services concerning the agency's proposed rule on interoperability standards and prior authorization for drugs under Medicare Advantage, Medicaid Managed Care, CHIP, and Qualified Health Plan programs. The College highlighted the challenges posed by prior authorization processes and offered recommendations to improve transparency, timeliness, and scope of CMS's initiatives.
The organizatio more ST
American Council of Engineering Companies Seeks Clarification on Accessibility Rule for Technical Deliverables (10)
WASHINGTON, July 3 -- The American Council of Engineering Companies has raised concerns with the U.S. Department of Justice regarding the implementation of Web Content Accessibility Guidelines Level 2.1 AA requirements for state and local government websites and mobile applications. The public comment letter highlights that the engineering sector finds compliance difficult for complex engineering project deliverables required by public agencies.
The council explained that engineering documents often encompass detailed drawings, 3D models, geos more ST
American Foundation for the Blind Opposes Department of Justice Delay of Web Accessibility Compliance Dates (10)
WASHINGTON, July 3 -- The American Foundation for the Blind, Arlington, Virginia, has submitted a public comment letter to the U.S. Department of Justice opposing the extension of compliance dates for web and mobile app accessibility rules under the Americans with Disabilities Act Title II. The DOJ had proposed delaying the deadlines related to the accessibility of web information and services of state and local government entities, a move the AFB argues would continue to impose significant barriers on millions of Americans with vision disabili more ST
American Hospital Association Urges Centers for Medicare & Medicaid Services to Strengthen Prior Authorization and Interoperability Rules (10)
WASHINGTON, July 3 -- The American Hospital Association has submitted a public comment letter to the Centers for Medicare & Medicaid Services expressing support for the agency's proposed regulations aimed at modernizing prior authorization processes and advancing interoperability standards. The letter, addressed to CMS leadership and officials at the U.S. Department of Health and Human Services and the Office of the National Coordinator for Health Information Technology, highlights critical recommendations to improve timely patient access and r more ST
American Podiatric Medical Association Urges Improvements in Prior Authorization for Medicare and Medicaid (10)
WASHINGTON, July 3 -- The American Podiatric Medical Association, Bethesda, Maryland, submitted a public comment letter to the U.S. Department of Health and Human Services Centers for Medicare & Medicaid Services addressing proposals to enhance interoperability standards and prior authorization for drugs under Medicare Advantage, Medicaid managed care, the Children's Health Insurance Program, and qualified health plans on federally-facilitated exchanges. APMA emphasized the importance of timely patient access to necessary care and the reduction more ST
American Society for Transplantation and Cellular Therapy Seeks Clarifications on Centers for Medicare & Medicaid Services Prior Authorization Rule (10)
WASHINGTON, July 3 -- The American Society for Transplantation and Cellular Therapy, Chicago, Illinois, submitted a public comment letter to the Centers for Medicare & Medicaid Services regarding the 2026 proposed rule on Interoperability Standards and Prior Authorization for Drugs. ASTCT emphasized the importance of applying the rule uniformly to out-of-network and out-of-state providers, especially for specialized cell therapies used to treat life-threatening illnesses such as blood cancers.
ASTCT raised concerns about Medicare Advantage (MA more ST
American Society of Civil Engineers Urges Enhancements to Bureau of Transportation Statistics Data and Reporting (10)
WASHINGTON, July 3 -- The American Society of Civil Engineers, Reston, Virginia, has submitted a public comment letter to the U.S. Department of Transportation Bureau of Transportation Statistics addressing improvements in BTS products, user experience, and addressing data gaps across the transportation sector. ASCE, representing over 160,000 civil engineering professionals spanning aviation, railroads, roads, and other modalities, emphasized the importance of BTS data in informing infrastructure assessments and advocacy efforts.
ASCE highligh more ST
American Society of Dentist Anesthesiologists Urges CMS to Exclude Stand-Alone Dental Plans From Interoperability Rules (10)
WASHINGTON, July 3 -- The American Society of Dentist Anesthesiologists, Bartlett, Illinois, has submitted a public comment letter to the Centers for Medicare & Medicaid Services regarding CMS's 2026 Interoperability Standards and Prior Authorization for Drugs Proposed Rule. The organization emphasized that stand-alone dental plan issuers should remain exempt from these interoperability and prior authorization requirements due to the current lack of electronic dental record systems capable of complying with applicable standards such as HL7 and more ST
American Society of Hematology Urges Centers for Medicare & Medicaid Services to Standardize Electronic Prior Authorization for Drugs (10)
WASHINGTON, July 3 -- The American Society of Hematology has submitted a public comment letter to the Centers for Medicare & Medicaid Services advocating for improvements in the interoperability standards and prior authorization processes for drugs under Medicare and Medicaid programs. ASH, representing over 18,000 clinicians and scientists specializing in blood disorders, supports the agency's initiative to modernize electronic prior authorization procedures to reduce administrative burden and enhance patient care.
ASH highlighted ongoing cha more ST
American Society of Pediatric Nephrology Urges Centers for Medicare & Medicaid Services to Improve Drug Prior Authorization for Children With Kidney Disease (10)
WASHINGTON, July 3 -- The American Society of Pediatric Nephrology, McLean, Virginia, has submitted a public comment letter to the Centers for Medicare & Medicaid Services urging the agency to advance interoperability standards and improve prior authorization processes for drugs within Medicare Advantage, Medicaid Managed Care, Children's Health Insurance Program agencies, and qualified health plan issuers. ASPN advocates for reforms aimed at reducing administrative burdens and ensuring timely access to necessary medications for children with k more ST
American Urological Association Urges Broad and Patient-Centered AI Pilot in Clinical Trials (10)
WASHINGTON, July 3 -- The American Urological Association, Linthicum Heights, Maryland, has submitted a public comment letter to the U.S. Food and Drug Administration regarding the agency's AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. The association advocates a comprehensive and patient-centric approach for the pilot designed to enhance clinical trial efficiency, participant safety, and data integrity through artificial intelligence applications.
The American Urological Association (AUA), representing over 22,000 memb more ST
American Urological Association Urges Improvements in Medicare Prior Authorization Process (10)
WASHINGTON, July 3 -- The American Urological Association, Linthicum Heights, Maryland, submitted a public comment letter to the Centers for Medicare & Medicaid Services regarding the proposed rule on Interoperability Standards and Prior Authorization for Drugs. The AUA expressed appreciation for CMS's efforts to reduce administrative burdens through enhancing electronic prior authorization processes but highlighted ongoing challenges.
The AUA emphasized that prior authorization requirements continue to impose significant administrative burden more ST
Americans for Scientific Integrity Submits =Evidence to Food and Drug Administration Backing Warning Labels on Pediatric Acetaminophen (10)
WASHINGTON, July 3 -- Americans for Scientific Integrity, San Antonio, Texas, submitted a supplemental public comment letter to the U.S. Food and Drug Administration supporting a prior citizen petition requesting precautionary warnings on over-the-counter acetaminophen products intended for infants and children. The petition urges inclusion of allergy-related safety information concerning asthma, rhinoconjunctivitis, and eczema.
The organization points to new studies providing stronger evidence linking early acetaminophen exposure to respirato more ST
Amgen Highlights Concerns Over Step Therapy and Prior Authorization in Medicare and Medicaid Programs (10)
WASHINGTON, July 3 -- Amgen, Thousand Oaks, California, has submitted a public comment letter to the Centers for Medicare & Medicaid Services concerning the agency's Proposed Rule on interoperability standards and prior authorization for drugs used in Medicare Advantage, Medicaid Managed Care, Children's Health Insurance Program agencies, and issuers of qualified health plans on the federally-facilitated exchanges. The letter addresses concerns about utilization management policies, especially step therapy, and its impact on patient access to t more ST
Anthropic Offers Recommendations on Food and Drug Administration's AI Optimization of Early-Phase Clinical Trials Pilot Program (10)
WASHINGTON, July 3 -- Anthropic, an artificial intelligence safety and research company in San Francisco, California, has submitted a public comment letter to the U.S. Food and Drug Administration regarding the agency's AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. The letter addresses questions from the perspective of a general-purpose AI model developer and proposes recommendations aimed at enhancing the pilot's framework to ensure effective evaluation and oversight of AI-enabled tools used in clinical trials.
Anthrop more ST
Arclio Proposes Mechanically Verifiable Evidence Standards for Food and Drug Administration AI Pilot in Clinical Trials (10)
WASHINGTON, July 3 -- Arclio LLC, New York, has submitted a public comment letter to the Food and Drug Administration regarding the agency's AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. In its letter, Arclio advocates for the pilot program to be structured around mechanically verifiable evidence rather than reliance on narrative audit logs. The company stresses that adopting independently verifiable evidence obligations will better support regulatory review of AI-driven clinical trial decisions than existing methods.
A more ST
Arcwood Environmental Highlights Advancements and Recommendations on PFAS Destruction Guidance (10)
WASHINGTON, July 3 -- Arcwood Environmental, Cincinnati, Ohio, a provider of full-service solutions for the management and disposal of per- and polyfluoroalkyl substances materials, submitted a public comment letter to the U.S. Environmental Protection Agency regarding the agency's 2026 Interim PFAS Destruction and Disposal Guidance. The letter addresses recent developments in thermal treatment research, advocates for site-specific performance assessment, and offers recommendations to refine EPA's approach to PFAS destruction standards.
Arcwoo more ST
Arthritis Foundation Urges Centers for Medicare and Medicaid Services to Enhance Prior Authorization Processes for Prescription Drugs (10)
WASHINGTON, July 3 -- The Arthritis Foundation, Atlanta, Georgia, has submitted a public comment letter to the U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services addressing the agency's proposed rule. The rule aims to expand access to health information and improve the prior authorization process for prescription drugs, a critical process affecting nearly 60 million American adults and 300,000 children impacted by arthritis.
The Arthritis Foundation's commentary builds on prior feedback on CMS-0057, which e more ST
Artificer Health Urges Stronger Medicare and Medicaid Prior Authorization Rules to Reduce Clinician Burden and Improve Patient Safety (10)
WASHINGTON, July 3 -- Artificer Health Inc., Lakeland, Florida, has submitted a public comment letter to the U.S. Department of Health and Human Services Centers for Medicare & Medicaid Services regarding the proposed rule CMS0062P. The rule aims to strengthen interoperability standards and streamline prior authorization processes for drugs under Medicare and Medicaid programs. Artificer Health endorses the agency's regulatory direction but recommends several key enhancements to amplify the rule's impact on clinician workload, patient access, a more ST
Association for Clinical Oncology Urges Centers for Medicare & Medicaid Services to Improve Prior Authorization Processes for Cancer Care Drugs (10)
WASHINGTON, July 3 -- The Association for Clinical Oncology, Alexandria, Virginia, submitted a public comment letter to the Centers for Medicare & Medicaid Services addressing the agency's 2026 proposed rule on interoperability standards and prior authorization for drugs under Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Children's Health Insurance Program Agencies, CHIP Managed Care Entities, and issuers of Qualified Health Plans on the Federally-Facilitated Exchanges.
ASCO, representing over 50,000 more ST
Association for Molecular Pathology Highlights Challenges and Opportunities in Prior Authorization for Laboratory Testing (10)
WASHINGTON, July 3 -- The Association for Molecular Pathology, Rockville, Maryland, has submitted a public comment letter to the Centers for Medicare & Medicaid Services concerning the proposed changes to interoperability standards for prior authorization under Medicare and Medicaid programs. The organization, representing over 3,100 professionals in molecular biology and genomic testing, discussed administrative burdens, patient care impacts, and technological opportunities in prior authorization processes for laboratory services.
The associa more ST
Association of American Publishers Proposes Fee Structure Reforms to U.S. Copyright Office (10)
WASHINGTON, July 3 -- The Association of American Publishers submitted a public comment letter to the U.S. Copyright Office outlining recommendations for alternative fee structures related to copyright registration. The trade association urges the agency to develop a detailed understanding of costs associated with various work types and registration options before implementing fee differentiation.
The association highlights that examination costs vary widely across work categories, noting, for example, the higher expenses for literary work reg more ST
Association of Cancer Care Centers Urges Centers for Medicare and Medicaid Services to Strengthen Prior Authorization Rules for Cancer Care (10)
WASHINGTON, July 3 -- The Association of Cancer Care Centers, Rockville, Maryland, has submitted a public comment letter to the Centers for Medicare and Medicaid Services regarding the agency's proposed rule on Medicare and Medicaid Programs addressing patient protection, interoperability standards, and prior authorization for drugs among Medicare Advantage organizations, Medicaid managed care plans, and qualified health plans on the federally facilitated exchanges. The ACCC provided detailed feedback on provisions related to required timeframe more ST
Association of Clinical Research Organizations Urges Expanded CRO Role in Food and Drug Administration AI Clinical Trial Pilot Program (10)
WASHINGTON, July 3 -- The Association of Clinical Research Organizations, a nonprofit trade association representing leading global clinical research and technology organizations, submitted a public comment letter to the U.S. Food and Drug Administration regarding the agency's AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. ACRO emphasizes the central role that contract research organizations play in the execution and innovation of global clinical trials and urges FDA to explicitly include CROs as direct participants in th more ST
Association of Medical Illustrators Proposes Fee and Process Changes to U.S. Copyright Office (10)
WASHINGTON, July 3 -- The Association of Medical Illustrators, Lexington, Kentucky, submitted a public comment letter to the U.S. Copyright Office addressing alternative fee structures for copyright registration. AMI advocates for a reduced-fee administrative correction process to amend non-substantive errors such as publication status without forfeiting the original effective date of registration.
AMI highlights the challenges faced by independent and small business medical illustrators who rely on copyright registration as a legal requisite more ST
Asthma and Allergy Foundation Urges Centers for Medicare & Medicaid Services to Improve Prior Authorization and Step Therapy Rules (10)
WASHINGTON, July 3 -- The Asthma and Allergy Foundation, Arlington, Virginia, submitted a public comment letter to the Centers for Medicare & Medicaid Services addressing proposed rules on interoperability standards and prior authorization for drug coverage within Medicare and Medicaid programs.
The foundation, which advocates for people with asthma and allergies, highlighted the burden asthma places on nearly 28 million Americans and emphasized how prior authorization and step therapy requirements often delay or block timely access to effecti more ST
AstraZeneca Urges CMS to Strengthen Prior Authorization Reforms to Protect Rare Disease Patients (10)
WASHINGTON, July 3 -- AstraZeneca, Wilmington, Delaware, submitted a public comment letter to the Centers for Medicare & Medicaid Services regarding the agency's proposed rule on interoperability standards and prior authorization requirements for prescription drugs under Medicare Advantage, Medicaid, the Children's Health Insurance Program, and qualified health plans on federally facilitated exchanges. The letter responds in detail to CMS's April 2026 proposal aimed at improving transparency and efficiency in prior authorization processes, whic more ST
Athenahealth Calls for Extended Timeline and Greater Transparency in CMS Prior Authorization Rules (10)
WASHINGTON, July 3 -- Athenahealth, a Watertown, Massachusetts-based healthcare network provider, submitted a public comment letter to the Centers for Medicare & Medicaid Services expressing support for proposed prior authorization interoperability standards across Medicare Advantage, Medicaid managed care, CHIP, and Qualified Health Plans. The letter emphasizes benefits of expanding electronic prior authorization APIs to drug coverage under medical benefits, aiming to streamline administrative processes and improve patient care timeliness.
At more ST
Autistic Self Advocacy Network Opposes DOJ Delay of Web Accessibility Compliance Dates (10)
WASHINGTON, July 3 -- The Autistic Self Advocacy Network, a disability rights nonprofit in Washington, California, has submitted a public comment letter opposing the U.S. Department of Justice's Interim Final Rule extending compliance dates for web and mobile accessibility standards under the Americans with Disabilities Act. The DOJ's rule delayed the deadlines set forth in its 2024 Final Rule aimed at making websites and mobile applications of state and local governments accessible to individuals with disabilities, a move ASAN argues undermine more ST
Avalon Healthcare Solutions Urges Centers for Medicare and Medicaid Services to Enhance Prior Authorization for Laboratory Tests (10)
WASHINGTON, July 3 -- Avalon Healthcare Solutions, Tampa, Florida, submitted a public comment letter to the Centers for Medicare & Medicaid Services outlining recommendations to improve prior authorization processes for laboratory tests under Medicare and Medicaid programs. Avalon's extensive experience managing laboratory benefits for health plans covering over 90 million individuals nationwide informs their critique and suggestions regarding CMS's proposed rule on interoperability standards and prior authorization requirements, particularly p more ST
AyurDatta Solutions Urges Structured Human Oversight in AI-Assisted Clinical Trials (10)
WASHINGTON, July 3 -- AyurDatta Solutions, a physician-led clinical safety and governance firm in New York, submitted a public comment letter to the Food and Drug Administration regarding the AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. The firm emphasized the importance of integrating documented human judgment alongside AI outputs in clinical trial safety monitoring, particularly in high-risk oncology and cell and gene therapy trials.
The company advocated prioritizing first-in-human and oncology dose-escalation trial more ST
Bamboo Health Urges Centers for Medicare and Medicaid Services to Preserve HL7 V2 ADT for Patient Event Notifications While Supporting FHIR Modernization (10)
WASHINGTON, July 3 -- Bamboo Health, a care coordination technology company in Reston, Virginia, has provided comprehensive feedback to the Centers for Medicare & Medicaid Services on electronic event notifications for value-based care and care coordination. The public comment letter to the U.S. Department of Health and Human Services emphasizes preserving existing real-time event notification capabilities while cautiously advancing the adoption of newer standards.
In its response to CMS's Request for Information (RFI) on electronic event noti more ST
Barry Sample Consulting Urges Food and Drug Administration to Finalize Expansion of 510(k) Exemptions for Federal Workplace Drug Testing Devices (10)
WASHINGTON, July 3 -- Barry Sample Consulting, Boston, Massachusetts, has submitted a public comment letter to the Food and Drug Administration advocating for prompt finalization of the agency's proposed expansion to the 510(k) exemption framework. The proposal seeks to remove the long-standing exclusion of clinical toxicology test systems intended for federally regulated workplace drug testing programs from the Employment & Insurance exemption. The comment highlights the regulatory challenges and market uncertainties created by this exclusion more ST
Battelle Urges Department of Energy to Reconsider Sunsetting Key Regulations Affecting National Labs (10)
WASHINGTON, July 3 -- Battelle Memorial Institute, Columbus, Ohio, which operates the Department of Energy's Pacific Northwest National Laboratory, has expressed concerns to the U.S. Department of Energy regarding the proposed sunsetting of several critical regulations in the agency's Zero-Based Regulating Notice of Proposed Rulemaking. Battelle's public comment letter highlights the risks that removing these regulations would pose to national security, research innovation, and operational uniformity across the DOE national laboratory complex.
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Biodesix Calls for CMS Action to Limit Prior Authorization Barriers for Medicare Laboratory Tests (10)
WASHINGTON, July 3 -- Biodesix Inc., a biotechnology company in Boulder, Colorado, has submitted a public comment letter to the Centers for Medicare & Medicaid Services addressing the agency's Request for Information on interoperability standards and prior authorization for laboratory tests. Biodesix voiced support for the agency's efforts to reduce prior authorization practices used by Medicare Advantage Organizations that can impede patient access to clinically necessary laboratory services covered under National Coverage Determinations and L more ST
BioinvestGPT Proposes AI Tool Evaluation Standard to Enhance Early-Phase Clinical Trial Decisions (10)
WASHINGTON, July 3 -- BioinvestGPT ApS, a biotechnology company in Copenhagen, Denmark, submitted a public comment letter to the U.S. Food and Drug Administration regarding the agency's request for information on the AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. The letter outlines a proposed ten-element evidentiary standard for qualifying AI tools designed to independently predict the effectiveness of investigational drugs at the critical Phase 1 to Phase 2 transition in clinical trials.
BioinvestGPT's submission under more ST
Biotechnology Innovation Organization Urges Patient-Focused Prior Authorization Reforms in Comments to Centers for Medicare & Medicaid Services (10)
WASHINGTON, July 3 -- The Biotechnology Innovation Organization has submitted a public comment letter to the U.S. Department of Health and Human Services Centers for Medicare & Medicaid Services. The letter addresses CMS's proposed rule on interoperability standards and prior authorization for drugs within Medicare Advantage Organizations, Medicaid managed care plans, state Medicaid agencies, the Children's Health Insurance Program, CHIP managed care entities, and issuers of qualified health plans on federally facilitated exchanges.
The organi more ST
BJC Health Advocates for Enhanced Electronic Prior Authorization Rules and Enforcement to Improve Patient Access (10)
WASHINGTON, July 3 -- BJC Health, a healthcare system in St. Louis, Missouri, submitted a public comment letter to the Centers for Medicare and Medicaid Services regarding proposed rules to expand electronic prior authorization requirements for drugs under Medicare and Medicaid programs. The letter addresses the Centers for Medicare and Medicaid Services' current proposals to implement electronic prior authorization for pharmaceuticals, expanding on the prior 2024 final rule which excluded outpatient and retail prescription drugs from such mand more ST
Black Warrior Riverkeeper Urges Environmental Protection Agency to Maintain Protections Against Coal Ash Pollution (10)
WASHINGTON, July 3 -- Black Warrior Riverkeeper, a nonprofit advocacy organization in Birmingham, Alabama, submitted a public comment letter to the U.S. Environmental Protection Agency opposing the agency's proposed amendments to coal combustion residuals management rules. The organization expressed concerns that the proposed revisions would weaken existing safeguards under the 2015 Coal Ash Rule and the 2024 Legacy Coal Ash Rule, threatening water quality and public health in Alabama and beyond.
The letter highlights the presence of more than more ST
Blood Cancer United Advocates for Enhanced Electronic Prior Authorization Standards and Transparency (10)
WASHINGTON, July 3 -- Blood Cancer United, a patient-focused organization dedicated to curing blood cancers and improving patient quality of life, has submitted a public comment letter to the U.S. Department of Health and Human Services and the Centers for Medicare and Medicaid Services. The letter addresses the 2026 CMS Interoperability Standards and Prior Authorization for Drugs proposed rule, emphasizing key changes to prior authorization processes and interoperability standards as vital to improving patient access and care coordination.
Bl more ST
Blue Cross Blue Shield Association Urges Centers for Medicare & Medicaid Services to Extend Deadlines and Clarify Standards for Drug Prior Authorization APIs (10)
WASHINGTON, July 3 -- The Blue Cross Blue Shield Association has submitted a public comment letter to the Centers for Medicare & Medicaid Services and the U.S. Department of Health and Human Services on the 2026 Interoperability Standards and Prior Authorization for Drugs Proposed Rule. The letter outlines several detailed recommendations focused on technical and operational aspects of implementing electronic prior authorization for prescription drugs through standardized application programming interfaces.
BCBSA represents a federation of com more ST
Blue Cross Blue Shield of Massachusetts Urges Careful Implementation of Centers for Medicare & Medicaid Services Interoperability Standards and Prior Authorization Rule (10)
WASHINGTON, July 3 -- Blue Cross Blue Shield, Massachusetts, Boston, submitted a public comment letter to the Centers for Medicare & Medicaid Services regarding the agency's proposed Interoperability Standards and Prior Authorization for Drugs rule. The health plan acknowledged the need to streamline prior authorization processes but urged the agency to adopt a measured approach that balances administrative burden with cost management.Â
The commenter expressed support for integrating drugs covered under a medical benefit into the existing Pri more ST
Blue Ridge Health Urges Centers for Medicare & Medicaid Services to Strengthen Interoperability and Prior Authorization Reforms to Aid Medically Underserved Communities (10)
WASHINGTON, July 3 -- Blue Ridge Health, a community health center in Asheville, North Carolina, has submitted a public comment letter to the Centers for Medicare & Medicaid Services addressing the agency's 2026 proposed rule on interoperability standards and prior authorization for drugs. The letter highlights the pressing need for reforms that reduce administrative burdens and improve timely patient access to medically necessary care and prescription medications for vulnerable populations served by community health centers.
Blue Ridge Health more ST
Blue Shield of California Supports Enhancements to Interoperability and Prior Authorization Standards (10)
WASHINGTON, July 3 -- Blue Shield of California, a nonprofit health plan in San Francisco, submitted a public comment letter to the U.S. Department of Health and Human Services Centers for Medicare & Medicaid Services. The correspondence responds to the CMS Proposed Rule on Interoperability Standards and Prior Authorization for Drugs affecting Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Children's Health Insurance Program Agencies, CHIP Managed Care Entities, and issuers on the Federally-Facilitated E more ST
Boehringer Ingelheim Urges Enhanced Transparency and Patient Protections in Medicare and Medicaid Prior Authorization Policies (10)
WASHINGTON, July 3 -- Boehringer Ingelheim Pharmaceuticals, Ridgefield, Connecticut, has submitted a public comment letter to the Centers for Medicare and Medicaid Services responding to the agency's proposed rule addressing interoperability standards and prior authorization requirements for drugs under Medicare Advantage, Medicaid managed care, the Children's Health Insurance Program, and Marketplace plans. The biopharmaceutical company emphasizes the role prior authorization and utilization management practices play in patient access to thera more ST
Borinquen Health Care Center Supports Centers for Medicare & Medicaid Services Proposals to Enhance Prior Authorization and Interoperability Standards (10)
WASHINGTON, July 3 -- Borinquen Health Care Center, a Federally Qualified Health Center in Miami, Florida, has expressed support for the Centers for Medicare & Medicaid Services' proposed rule aimed at improving interoperability standards and prior authorization processes for drugs across Medicare Advantage, Medicaid managed care, Children's Health Insurance Program, and qualified health plans on the federally-facilitated exchange. The health center, serving a predominantly low-income and culturally diverse patient population in Miami-Dade Coun more ST
Bristol Myers Squibb Urges Centers for Medicare & Medicaid Services to Strengthen Prior Authorization Policies to Improve Patient Access to Prescription Drugs (10)
WASHINGTON, July 3 -- Bristol Myers Squibb, Princeton, New Jersey has submitted a public comment letter to the Centers for Medicare & Medicaid Services regarding the agency's Proposed Rule on interoperability standards and prior authorization protections for prescription drugs under Medicare Advantage organizations, Medicaid managed care plans, state Medicaid agencies, Children's Health Insurance Program agencies, CHIP managed care entities, and issuers of Qualified Health Plans on the Federally-Facilitated Exchanges. The pharmaceutical company more ST
Bromme Hampton Cole Applauds Improvements in AbilityOne's New Strategic Plan, Urges Stronger Governance (10)
WASHINGTON, July 3 -- Bromme Hampton Cole, a nonprofit organization specializing in governance reform and nonprofit accountability in Arlington, Virginia, has submitted a public comment letter concerning the U.S. AbilityOne Commission's Draft Strategic Plan for Fiscal Years 2026 through 2030. The letter commends the Commission for significant improvements in its strategic planning while urging stronger focus on governance, accountability, and structural vulnerabilities that could impact the program's long-term effectiveness.
The comment letter more ST
Brotherhood of Maintenance of Way Employees Division Challenges CSX Automated Track Inspection Waiver Implementation (10)
WASHINGTON, July 3 -- The Brotherhood of Maintenance of Way Employees Division of the International Brotherhood of Teamsters has submitted a public comment letter to the Federal Railroad Administration expressing opposition to CSX Transportation's plan to implement operations under the Automated Track Inspection waiver. The federal agency is part of the U.S. Department of Transportation and is tasked with overseeing the safety and regulation of railroad operations nationwide.
The Brotherhood represents skilled railroad workers charged with ins more ST
Buckeye Power Urges Environmental Protection Agency to Rescind CCRMU Program and Revise Coal Combustion Residual Rules (10)
WASHINGTON, July 3 -- Buckeye Power Inc., an Ohio-based electric cooperative, submitted a public comment letter to the U.S. Environmental Protection Agency regarding the agency's proposed amendments to the Hazardous and Solid Waste Management System for Disposal of Coal Combustion Residuals. The nonprofit cooperative, which operates coal-fired power units near Brilliant, Ohio, outlined concerns that the Proposed Rule fails to fully address legal, technical, and implementation challenges in managing legacy coal combustion residual management uni more ST
Burna AI Urges Food and Drug Administration to Prioritize AI-Assisted Safety Monitoring in Early-Phase Oncology Trials (10)
WASHINGTON, July 3 -- Burna AI, a Chicago, Illinois-based company specializing in safety and data quality infrastructure for oncology drug development, has submitted a public comment letter to the U.S. Food and Drug Administration regarding the agency's AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. The company advocates for the pilot to prioritize real-time safety monitoring, particularly through AI-assisted adverse event grading and safety signal detection in early-phase oncology trials, where adverse event volume and s more ST
California Clinical Laboratory Association Calls for Prior Authorization Reform in Medicare Advantage Program (10)
WASHINGTON, July 3 -- The California Clinical Laboratory Association, Sacramento, submitted a public comment letter to the Centers for Medicare & Medicaid Services addressing the negative impacts of prior authorization requirements on patient care and the administrative burdens experienced by clinical laboratories, particularly within the Medicare Advantage program. The letter responds to CMS's Request for Information on prior authorization for laboratory tests and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies included in the more ST
CancerCare Urges Centers for Medicare and Medicaid Services to Strengthen Prior Authorization Rules for Prescription Drugs (10)
WASHINGTON, July 3 -- CancerCare, New York, submitted a public comment letter to the Centers for Medicare & Medicaid Services regarding the proposed rule on prior authorization for drugs and Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Children's Health Insurance Program agencies, and issuers of qualified health plans on federally-facilitated exchanges. The organization applauded CMS's efforts to extend prior authorization requirements to prescription drugs but emphasized the heavy burden current proce more ST
Capital District Physicians' Health Plan Supports CMS's Interoperability Standards With Recommendations for Extended Timeline (10)
WASHINGTON, July 3 -- Capital District Physicians' Health Plan Inc., a physician founded, not-for-profit health plan headquartered in Albany, New York, has submitted a public comment letter to the Centers for Medicare & Medicaid Services regarding the 2026 Interoperability Standards and Prior Authorization for Drugs Proposed Rule. CDPHP serves over 56,000 Medicare Advantage members primarily in Upstate New York's Capital Region and has been recognized for high quality with 4.5 out of 5 star ratings.
In its letter to CMS, CDPHP expressed suppor more ST
CCS Medical Addresses Prior Authorization Challenges in Medicare Programs (10)
WASHINGTON, July 3 -- CCS Medical Inc., St. Petersburg, Florida, submitted a public comment letter to the Centers for Medicare and Medicaid Services regarding the proposed rule on interoperability standards and prior authorization for drugs within Medicare Advantage organizations, Medicaid programs, and federally-facilitated exchanges. The comment focuses on prior authorization issues related to Laboratory Tests and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies items.
As the largest distributor of insulin pumps and continuous more ST
Center for Biological Diversity Challenges U.S. Fish and Wildlife Service Over Proposed Rule Changes (10)
WASHINGTON, July 3 -- The Center for Biological Diversity, Tucson, Arizona, has submitted a public comment letter to the U.S. Fish and Wildlife Service opposing a proposed rule that aims to expand hunting and fishing access across more than 2.5 million acres of public lands, encompassing 95 percent of the National Wildlife Refuge System. The organization expresses concern that the proposal undermines longstanding conservation efforts and prioritizes the interests of hunting and fishing lobbies over ecological science and the majority of non-hun more ST
ChenMed Calls for Enhanced Standards in Patient Event Notifications to Improve Care Coordination (10)
WASHINGTON, July 3 -- ChenMed, a Miami, Florida-based value-based care organization specializing in primary care for high-risk Medicare beneficiaries, has outlined a series of recommendations aimed at improving the quality and effectiveness of patient event notifications sent by hospitals. In a public comment letter submitted to the Centers for Medicare & Medicaid Services, ChenMed emphasized the role that timely, comprehensive hospital event alerts play in ensuring safe care transitions, preventing avoidable readmissions, and supporting effect more ST
Children's Tumor Foundation Urges FDA to Focus on Unlocking Shelved Rare Disease Drugs (10)
WASHINGTON, July 3 -- The Children's Tumor Foundation, New York, has submitted a public comment letter to the U.S. Food and Drug Administration advocating for a Rare Disease Innovation Hub workshop in fall 2026. The organization proposed examining how drug repositioning, data access, and public-private collaboration can unlock shelved pharmaceutical assets to accelerate treatment availability for rare disease patients.
The foundation highlighted the untapped potential of approximately 5,000 shelved compounds with Phase 1 safety data that pharm more ST
Clinical Reference Laboratory Urges Food and Drug Administration to Expand Premarket Exemptions for Federal Drug Testing Devices (10)
WASHINGTON, July 3 -- Clinical Reference Laboratory Inc., Lenexa, Kansas, submitted a public comment letter to the Food and Drug Administration regarding the agency's proposal to expand premarket notification exemptions for certain Class II clinical toxicology test systems used in Federal drug testing programs. The laboratory operator supports the FDA's plan to remove a current limitation that excludes devices intended for use in Federal workplace drug testing programs from premarket notification exemptions. This policy change would reduce dupl more ST
College of American Pathologists Highlights Challenges of Prior Authorization in Laboratory Testing (10)
WASHINGTON, July 3 -- The College of American Pathologists, Northfield, Illinois, has submitted a public comment letter to the U.S. Department of Health and Human Services Centers for Medicare & Medicaid Services addressing concerns regarding the Request for Information on Laboratory Tests and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Items. The professional organization, known as the world's largest association of board-certified pathologists, outlined the profound implications prior authorization requirements have on lab more ST
Color of Gastrointestinal Illnesses Urges Centers for Medicare & Medicaid Services to Eliminate Drug Approval Delays (10)
WASHINGTON, July 3 -- The Color of Gastrointestinal Illnesses, Glenarden, Maryland, submitted a public comment letter to the Centers for Medicare & Medicaid Services regarding the agency's proposed rule on interoperability standards and prior authorization for drugs under Medicare and Medicaid programs. The organization, dedicated to improving quality of life for individuals affected by inflammatory bowel disease and other chronic digestive disorders, expressed support for CMS's efforts to reform prior authorization processes but urged further more ST
Colorado Parks and Wildlife Supports Expanded Hunting Opportunities on National Wildlife Refuges in Colorado (10)
WASHINGTON, July 3 -- Colorado Parks and Wildlife, Denver, has expressed support for the U.S. Fish and Wildlife Service's proposed updates to hunting and sportfishing regulations on National Wildlife Refuges across the state. In a public comment letter addressed to the U.S. Fish and Wildlife Service, CPW emphasized the importance of these updates in promoting sustainable outdoor recreation and effective wildlife management.
CPW outlined its statutory mission as maintaining Colorado's wildlife resources and providing quality outdoor recreationa more ST
Connected Health Initiative Advocates for Enhanced Interoperability and Electronic Prior Authorization in Centers for Medicare & Medicaid Services Proposed Rule (10)
WASHINGTON, July 3 -- The Connected Health Initiative has issued a public comment letter to the U.S. Department of Health and Human Services Centers for Medicare & Medicaid Services concerning the agency's proposed rule on interoperability standards and prior authorization for drugs. The letter provides detailed input on proposed amendments to the Medicare Promoting Interoperability Program, emphasizing the importance of connected health technologies in promoting patient access, reducing administrative burdens, and improving overall healthcare more ST
Consensus Cloud Solutions Urges Centers for Medicare & Medicaid Services to Recognize Intelligent Digital Fax in Prior Authorization Interoperability Rule (10)
WASHINGTON, July 3 -- Consensus Cloud Solutions, a Los Angeles, California-based provider of cloud-based digital fax and healthcare document exchange services, has submitted a public comment letter to the Centers of Medicare and Medicaid Services regarding the 2026 CMS Interoperability Standards and Prior Authorization for Drugs Proposed Rule. The company highlighted the ongoing reliance on digital fax alongside emerging FHIR API systems for exchanging prior authorization documents and recommended adjustments to ensure inclusive compliance path more ST
Consumer Brands Association Urges Food and Drug Administration to Enhance Flexibility and Clarity for Food Traceability Compliance (10)
WASHINGTON, July 3 -- The Consumer Brands Association, Arlington, Virginia, has submitted a public comment letter to the U.S. Food and Drug Administration expressing support for the agency's efforts on the Food Traceability Rule while advocating for additional flexibilities and clearer guidance to ease regulatory burdens. The association represents over 2,000 consumer packaged goods brands, emphasizing their critical role in the domestic manufacturing workforce and the U.S. economy.
The association praised FDA for various outreach initiatives more ST
Contexture Advocates for Health Information Exchanges to Enhance Patient Event Notifications (10)
WASHINGTON, July 3 -- Contexture, a leading nonprofit health information exchange organization in Phoenix, Arizona, has submitted a public comment letter to the U.S. Department of Health & Human Services Centers for Medicare & Medicaid Services addressing the Request for Information on Electronic Event Notifications for Value-Based Care and Care Coordination. Drawing on its operational experience across Arizona and Colorado, Contexture urged CMS to prioritize the state and regional HIE model as the foundation for improving the exchange and util more ST
Cooperative Exchange Addresses Centers for Medicare & Medicaid Services Proposal on Medicare and Medicaid Prior Authorization and Interoperability Standards (10)
WASHINGTON, July 3 -- The Cooperative Exchange, the National Clearinghouse Association based in Birmingham, Alabama, representing a network of 20 member organizations that facilitate healthcare electronic data exchange, submitted a public comment letter to the Centers for Medicare & Medicaid Services regarding the proposed rule. This rule addresses interoperability standards and prior authorization processes for Medicare Advantage Organizations, Medicaid Managed Care Plans, and others. The association, which supports over one million provider o more ST
CRISP Shared Services Urges Centers for Medicare & Medicaid Services to Prioritize Data Quality and HIEs in Patient Event Notification Rulemaking (10)
WASHINGTON, July 3 -- CRISP Shared Services Inc., a Baltimore, Maryland not-for-profit organization managing shared infrastructure for Health Information Exchanges and Health Data Utilities, has submitted a public comment letter to the Centers for Medicare & Medicaid Services addressing the proposed rule on interoperability standards and prior authorization for drugs under Medicare Advantage and Medicaid managed care programs. The letter highlights considerations for CMS to improve patient event notification systems and strengthen data exchange more ST
Crohn's & Colitis Foundation Urges CMS to Reform Prior Authorization and Step Therapy Policies for Inflammatory Bowel Disease Patients (10)
WASHINGTON, July 3 -- The Crohn's & Colitis Foundation, Bethesda, Maryland, has submitted a public comment letter to the Centers for Medicare & Medicaid Services regarding the agency's proposed rulemaking on prior authorization and step therapy protocols affecting Medicare Advantage organizations, Medicaid managed care plans, Children's Health Insurance Program agencies, and Qualified Health Plans on the Federally Facilitated Exchanges. The Foundation advocates for reforms intended to improve timely access to appropriate treatments for individu more ST
Cyntegrity Advocates for Focused AI Pilot Program to Optimize Early-Phase Clinical Trials (10)
WASHINGTON, July 3 -- Cyntegrity, Boston, Massachusetts, submitted a public comment letter to the U.S. Food and Drug Administration responding to its Request for Information on the AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. The company, specializing in risk-based quality management platforms with artificial intelligence capabilities, provided recommendations aimed at shaping a practical and impactful pilot study to integrate AI into early-phase clinical trial management.
Cyntegrity questioned the proposed pilot's ini more ST
Daiichi Sankyo Advocates for Risk-Based AI Pilot Program in Early-Phase Clinical Trials (10)
WASHINGTON, July 3 -- Daiichi Sankyo Inc., Basking Ridge, New Jersey, has provided a public comment letter to the U.S. Food and Drug Administration responding to the agency's Request for Information regarding the AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. The letter outlines comprehensive recommendations aimed at supporting the development and implementation of artificial intelligence technologies to enhance the efficiency, safety, and decision-making processes in early clinical trial phases.
Daiichi Sankyo emphasize more ST
Datavant Urges Enhanced Digital Identity and Cybersecurity Measures in Centers for Medicare & Medicaid Services Prior Authorization Rule Comments (10)
WASHINGTON, July 3 -- Datavant, a health data collaboration platform in San Francisco, California, submitted a public comment letter to the Centers for Medicare & Medicaid Services regarding the agency's proposed rule on interoperability standards and prior authorization for drugs. The company expressed support for the Administration's efforts to improve prior authorization while emphasizing the importance of advancing digital identity solutions and cybersecurity protections to secure health information exchange.
Datavant highlighted that exis more ST
Defacto Health Urges Centers for Medicare & Medicaid Services to Expand and Strengthen API Endpoint Reporting Requirements (10)
WASHINGTON, July 3 -- Defacto Health LLC, a healthcare data company based in Oakton, Virginia, has submitted a public comment letter to the Centers for Medicare & Medicaid Services regarding the proposed rule which concerns electronic prior authorization for drugs and the mandatory reporting of payer API endpoints. Defacto Health supports the proposal for mandatory endpoint reporting requirements but recommends expanding and enhancing those requirements to better serve consumers, developers, and regulators.
The company highlights that, since t more ST
Delta Air Lines Seeks Clarifications on Federal Aviation Administration Airworthiness Directive Proposal (10)
WASHINGTON, July 3 -- Delta Air Lines, Atlanta, Georgia, submitted a public comment letter to the U.S. Department of Transportation regarding the Federal Aviation Administration's proposed rule which addresses airworthiness directives linked to slat track inspections and repairs. Delta's comments focus on the alignment between existing FAA Airworthiness Directive 2022-25-05 and related Transport Canada Civil Aviation ADs, as well as on operational clarifications for U.S. operators.
Delta requested that the FAA add a paragraph or independent cr more ST
Department of Energy's Proposal for Periodic Regulatory Review Gains Endorsement From Main Street Foundation (10)
WASHINGTON, July 3 -- The Main Street Foundation, Boston, Massachusetts, has expressed its support for the U.S. Department of Energy's initiative to implement a structured system of periodic retrospective review and conditional sunset provisions for federal regulations. This proposal aims to ensure that regulations continue to meet their intended objectives over time, responding to evolving technologies, legal frameworks, and public needs.
The Main Street Foundation's Center for Regulatory Analysis and Engagement (CRAE) submitted a comprehensi more ST
Domino Data Lab Urges Focus on AI Decision Quality and Safety in Early-Phase Clinical Trials Pilot Program (10)
WASHINGTON, July 3 -- Domino Data Lab, a Boston, Massachusetts-based company specializing in data science and analytics platforms, has submitted a public comment letter to the U.S. Food and Drug Administration regarding the agency's "AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program." The letter offers detailed recommendations about how artificial intelligence can be integrated into early-phase clinical trials to improve decision-making quality, patient safety, and operational efficiency while maintaining scientific rigor and more ST
Eli Lilly Proposes Comprehensive Recommendations for Food and Drug Administration Pilot on AI in Early-Phase Clinical Trials (10)
WASHINGTON, July 3 -- Eli Lilly and Co., Indianapolis, Indiana, has submitted a public comment letter to the U.S. Food and Drug Administration outlining detailed recommendations for its AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. Drawing from extensive experience in integrating artificial intelligence across drug development stages, Lilly aims to assist the FDA in constructing a framework that advances responsible AI adoption in early clinical trial phases.
Lilly emphasized that AI has transformative potential for spe more ST
Emily's Entourage Proposes Workshop on Genetic Therapy Development for Cystic Fibrosis to Food and Drug Administration (10)
WASHINGTON, July 3 -- Emily's Entourage, a patient advocacy organization in Cambridge, Massachusetts, submitted a public comment letter to the U.S. Food and Drug Administration regarding future programming for the FDA Rare Disease Innovation Hub. The letter focuses on advancing regulatory science and development pathways for genetic therapies targeting the final 10 percent of people with cystic fibrosis who are not served by current mutation-targeted treatments.
Emily's Entourage advocates accelerating research and drug development for cystic more ST
EnergySolutions Submits Detailed Feedback on Environmental Protection Agency's PFAS Destruction and Disposal Guidance (10)
WASHINGTON, July 3 -- EnergySolutions, Salt Lake City, Utah, has provided comprehensive public comments to the U.S. Environmental Protection Agency concerning the Agency's 2026 Interim Guidance on the Destruction and Disposal of Perfluoroalkyl and Polyfluoroalkyl Substances and materials containing PFAS. The comments emphasize technical, regulatory, and operational considerations based on EnergySolutions' experience managing PFAS-containing waste, including radiologically impacted mixed waste, and urge refinements to enhance clarity and applica more ST
Evalion Urges Food and Drug Administration to Establish Evidence-Based Reliability Standards for AI in Early-Phase Clinical Trials (10)
WASHINGTON, July 3 -- Voice Eval Systems Inc. doing business as Evalion, San Francisco, California, has outlined recommendations for the U.S. Food and Drug Administration's AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. The company advocates for mandatory demonstration of evidence-based reliability for artificial intelligence agents deployed in consequential roles within clinical trials. Evalion further proposes that the pilot program explore AI's capacity to provide continuous operational oversight to enhance trial parti more ST
EVRESA Proposes Decision-Governance Framework for AI in Early-Phase Clinical Trials (10)
WASHINGTON, July 3 -- EVRESA LLC, an AI governance enforcement infrastructure company in Orlando, Florida, submitted a public comment letter to the U.S. Food and Drug Administration regarding the agency's AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. The letter emphasized the importance of embedding a robust decision-governance layer in AI-enabled clinical trial workflows to ensure human authority, participant safety, data integrity, and auditability of AI-influenced decisions. EVRESA advocates for integrating a tamper-e more ST
Facing Our Risk of Cancer Empowered Highlights Impact of Prior Authorization on Genetic Testing Access for Hereditary Cancer Patients (10)
WASHINGTON, July 3 -- Facing Our Risk of Cancer Empowered, a national nonprofit organization in Tampa, Florida, that represents individuals affected by hereditary cancers, has submitted a public comment letter to the Centers for Medicare & Medicaid Services. The letter addresses concerns regarding the effects of prior authorization requirements on laboratory testing, particularly genetic testing, for patients with or at risk of hereditary cancers. FORCE underlines how current prior authorization practices create barriers to timely and medically more ST
Families USA Urges Strengthened Prior Authorization and Interoperability Standards in Centers for Medicare & Medicaid Services Rule Proposal (10)
WASHINGTON, July 3 -- Families USA, a national health care consumer advocacy organization, has expressed support for the Centers for Medicare & Medicaid Services' 2026 proposed rule aiming to improve interoperability standards and prior authorization processes for Medicare Advantage organizations, Medicaid managed care plans, state Medicaid agencies, Children's Health Insurance Program agencies, CHIP managed care entities, and issuers of qualified health plans on federally-facilitated exchanges. In a public comment letter submitted to CMS, Fami more ST
Farm Credit Council Advocates for Streamlining Guaranteed Farm Loan Program With U.S. Department of Agriculture (10)
WASHINGTON, July 3 -- The Farm Credit Council has submitted a public comment letter to the U.S. Department of Agriculture Farm Service Agency regarding its information collection request tied to the Guaranteed Farm Loan Program. The FCC represents the Farm Credit System, a nationwide network of customer-owned financial institutions dedicated to supporting rural communities and agriculture.
In their letter, FCC highlights the critical role the Guaranteed Farm Loan Program plays in providing access to credit for agricultural producers and under more ST
Federal Public Defender Opposes Mississippi's Application for Capital Counsel Certification (10)
WASHINGTON, July 3 -- The Office of the Federal Public Defender for the Middle and Western Districts of Louisiana, Lafayette, submitted a public comment letter to the U.S. Department of Justice opposing the State of Mississippi's application for certification under 28 U.S.C. Sec. 2265. This application, filed by the Mississippi Attorney General, seeks federal recognition that the state meets certain criteria to receive expedited federal review in capital post-conviction proceedings. The federal defender office, representing clients including Ab more ST
FEMM Urges U.S. Department of Health to Adopt Evidence-Based Clinical Guidelines for Reproductive Health (10)
WASHINGTON, July 3 -- FEMM Fertility Education and Medical Management, San Francisco, California, has submitted a public comment letter to the U.S. Department of Health and Human Services advocating for the adoption of comprehensive, evidence-based clinical diagnostic guidelines to address reproductive disorders and infertility. FEMM's clinical framework, known as the Reproductive Health Research Institute Guidelines (2026), supports targeted evaluation and treatment of a wide range of reproductive health conditions affecting both women and men more ST
Fertilizer Institute Supports Environmental Protection Agency's Proposed New Source Review Construction Revisions to Streamline Permitting (10)
WASHINGTON, July 3 -- The Fertilizer Institute, representing the U.S. fertilizer industry, has submitted a public comment letter to the U.S. Environmental Protection Agency regarding its Proposed Rule titled "Begin Actual Construction in the New Source Review Preconstruction Permitting Program." The Fertilizer Institute expressed support for the agency's effort to revise the New Source Review rules to better distinguish between emissions-related and non-emitting construction activities prior to obtaining NSR permits.
TFI emphasized the vital r more ST
FGA Action Urges Stricter Safeguards for Medicaid Work Requirement Implementation (10)
WASHINGTON, July 3 -- FGA Action, Tallahassee, Florida, has expressed support for the Centers for Medicare and Medicaid Services' interim final rule establishing the Medicaid work requirement. The public comment letter to the U.S. Department of Health and Human Services applauds CMS for implementing integrity protections that uphold Congress's intent to hold able-bodied adults accountable. However, the organization raises concerns that states opposing the work requirement are poised to introduce loopholes and exemptions that could undermine the more ST
Flexpa Urges Centers for Medicare & Medicaid Services to Enhance Patient Access API Implementation and Compliance (10)
WASHINGTON, July 3 -- Flexpa, a healthcare technology company in Boston, Massachusetts, has submitted a public comment letter to the U.S. Department of Health and Human Services Centers for Medicare & Medicaid Services concerning proposed regulations aimed at improving interoperability standards and prior authorization for drugs under Medicare and Medicaid programs. The letter supports the goals of extending prior authorization requirements to drugs, specifying implementation guide versions, and requiring payers to report API endpoints, while e more ST
Florida Fruit & Vegetable Association Seeks Clarity on Food and Drug Administration Traceability Guidance (10)
WASHINGTON, July 3 -- The Florida Fruit & Vegetable Association, Maitland, Florida, offered comments to the U.S. Food and Drug Administration regarding draft guidance implementing the Food Safety Modernization Act Section 204 Traceability Rule. The association emphasized the necessity for the FDA's guidance to reflect the practicalities of specialty crop production and supply chain diversity to effectively protect consumers and prevent foodborne illness outbreaks.
The association called for clear baseline expectations for traceability lot code more ST
Florida Sugar Industry Supports Environmental Protection Agency Rule Changes to Begin Construction Before New Source Review Permit Issuance (10)
WASHINGTON, July 3 -- WSP USA Inc., representing the Florida Sugar Industry of Gainesville, Florida, submitted a public comment letter to the U.S. Environmental Protection Agency regarding the Proposed Rule on clarifying when actual construction can begin under the New Source Review preconstruction permitting program. The proposed revisions by the EPA aim to update the definition of "begin actual construction" and distinguish pollutant-emitting activities from non-emitting construction phases, allowing certain non-emitting activities to proceed more ST
Folia Health Urges Food and Drug Administration to Prioritize Real-Time Patient Experience Data in AI-Enabled Clinical Trials Pilot (10)
WASHINGTON, July 3 -- Folia Health, a patient-driven health informatics organization in Seattle, Washington state, has submitted a public comment letter to the U.S. Food and Drug Administration regarding the AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. The organization emphasized the need to incorporate continuous, real-time patient experience data into AI applications for clinical trials to enhance the quality and relevance of evidence generated in early-phase drug development.
Folia Health underscored that traditiona more ST
Genentech Urges Centers for Medicare and Medicaid Services to Enhance Transparency and Oversight on Step Therapy Protocols (10)
WASHINGTON, July 3 -- Genentech, a biotechnology company in South San Francisco, California, submitted a public comment letter to the Centers for Medicare & Medicaid Services addressing concerns related to proposed interoperability standards and prior authorization policies for Medicare and Medicaid programs. The company emphasized reforming the use of step therapy and prior authorization practices across public and commercial health plans to ensure timely patient access and to reduce administrative barriers undermining clinical care.
In its l more ST
Glacis Technologies Urges Food and Drug Administration to Judge Clinical Trial AI by Runtime Record, Not Internal Mechanics (10)
WASHINGTON, July 3 -- Glacis Technologies, Portland, Oregon has outlined recommendations for the U.S. Food and Drug Administration to consider in its AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. Their public comment letter emphasizes that trustworthiness for AI systems in early clinical trials should be assessed based on a verifiable runtime record of the system's actions rather than internal mechanics, aligning with principles from the National Institute of Standards and Technology Artificial Intelligence Risk Manageme more ST
Gov Contract Pros Calls for Extension of Comment Period on Federal Acquisition Regulatory Overhaul (10)
WASHINGTON, July 3 -- Gov Contract Pros, Chevy Chase, Maryland has submitted a public comment letter to the U.S. General Services Administration requesting an extension of the public comment period for four proposed rules associated with the Federal Acquisition Regulatory Council's Federal Acquisition Regulation Overhaul. The letter addresses FAR Case 2026-001, FAR Case 2026-002, FAR Case 2026-005, and FAR Case 2026-007.
The letter highlights that these four proposed rules, published by the FAR Council-which includes members from the Departmen more ST
Gov Contract Pros Requests Extended Comment Period for Federal Acquisition Regulation Overhaul (10)
WASHINGTON, July 3 -- Gov Contract Pros, a federal government contracting consulting firm in Chevy Chase, Maryland, has submitted a public comment letter to the U.S. General Services Administration's Office of Government-wide Acquisition Policy. The letter urges the Federal Acquisition Regulatory Council to extend the comment period for four proposed rules involved in the Revolutionary Federal Acquisition Regulation Overhaul. These rules, published jointly by the Department of Defense, GSA, National Aeronautics and Space Administration, and the more ST
Gov Contract Pros Requests Extension for FAR Overhaul Comment Period (10)
WASHINGTON, July 3 -- Gov Contract Pros, Chevy Chase, Maryland, submitted a public comment letter to the U.S. General Services Administration regarding the Federal Acquisition Regulatory Council's four proposed rules intended to overhaul the Federal Acquisition Regulation. These proposals, known as the Revolutionary FAR Overhaul, were published in the Federal Register and encompass extensive changes across multiple FAR parts that collectively impact hundreds of billions of acquisition dollars, numerous federal civil servants, and thousands of c more ST
GovContractPros Requests Longer Comment Period on Federal Acquisition Regulation Overhaul (10)
WASHINGTON, July 3 -- GovContractPros, Chevy Chase, Maryland, has submitted a public comment letter to the U.S. General Services Administration regarding four proposed rules under the Federal Acquisition Regulatory Council's Revolutionary Federal Acquisition Regulation Overhaul. The proposed rules include FAR Case 2026-001, 2026-002, 2026-005, and 2026-007, which collectively span over 214 pages and address significant changes across multiple FAR parts.
The FAR Council, composed of members from the Department of Defense, GSA, NASA, and the Off more ST
Government Contract Experts Urges AbilityOne Commission to Lower Program Fee Ceiling and Strengthen Subcontracting Rules (10)
WASHINGTON, July 3 -- Government Contract Experts, Arlington, Virginia, submitted a public comment letter to the U.S. AbilityOne Commission regarding the agency's proposed rulemaking on central nonprofit agency fees and subcontracting under the AbilityOne Program. The organization supports adjustments that enhance cost efficiency and transparency while maintaining the program's employment mission.
GCE advocates for a tiered program fee structure that reduces the current 3.75 percent fee ceiling to 2.75 percent at contract renewal. The group ar more ST
Graphic Artists Guild Proposes Equitable Fee Structures for Copyright Registration Modernization (10)
WASHINGTON, July 3 -- The Graphic Artists Guild Inc. in New York, submitted a public comment letter to the U.S. Copyright Office addressing the agency's Notice of Inquiry on Alternative Fee Structures for Registration. The letter offers insights on fee model proposals the agency is considering alongside updating its Enterprise Copyright System, emphasizing economic fairness, administrative feasibility, and accessibility for creators, particularly individual artists and small entities.
The Guild stresses that pricing models must recognize the e more ST
Harvard Medical School Pediatrics Professor Ha Cautions Against Revised OMB Rules on Federal Research Funding (10)
WASHINGTON, July 3 -- Taekjip Ha, Ph.D., professor of pediatrics at Harvard Medical School, Boston, Massachusetts, voiced concerns to the U.S. Office of Management and Budget regarding proposed changes to federal financial assistance regulations. Ha, a prominent molecular biophysicist and director at Boston Children's Hospital, highlighted the potential negative impacts on his laboratory's research, training programs, and collaborations in a public comment letter.
The letter criticizes the shift in Section 200.205 that would reduce the influen more ST
Health Level Seven International Endorses Centers for Medicare & Medicaid Services Proposed Rule to Enhance Healthcare Interoperability and Prior Authorization (10)
WASHINGTON, July 3 -- Health Level Seven International, Ann Arbor, Michigan, specializing in healthcare interoperability standards, has expressed support for the Centers for Medicare & Medicaid Services' Interoperability Standards and Prior Authorization for Drugs Proposed Rule. HL7 outlined its position in a public comment letter to CMS, the federal agency responsible for administering national healthcare programs under the U.S. Department of Health and Human Services.
HL7 underscores the rule as a foundational step for scalable API-based dat more ST
Healthcare Association of New York Urges Centers for Medicare and Medicaid Services to Strengthen Prior Authorization Standards (10)
WASHINGTON, July 3 -- The Healthcare Association of New York State, Albany, representing nonprofit and public hospitals and healthcare providers, expressed support for the U.S. Department of Health and Human Services' Centers for Medicare and Medicaid Services proposed rule to streamline prior authorization processes for prescription drugs and other services. The public comment letter submitted by the association emphasized the need for improvements that reduce administrative burdens and promote timely access to care.
The association applauded more ST
HealthEdge Software Highlights Implementation Challenges in CMS Prior Authorization Proposal (10)
WASHINGTON, July 3 -- HealthEdge Software Inc., a healthcare digital platform company in Boston, Massachusetts, has provided a public comment letter to the U.S. Department of Health and Human Services Centers for Medicare & Medicaid Services regarding the agency's proposed rule. The rule aims to expand electronic prior authorization requirements and interoperability standards for drugs under Medicare and Medicaid programs. HealthEdge's comments focus on the operational, technical, and vendor readiness implications of the proposals outlined in t more ST
HealthLX Urges Centers for Medicare & Medicaid Services to Enhance Interoperability and Prior Authorization Standards for Drug Coverage (10)
WASHINGTON, July 3 -- HealthLX, a health information technology vendor in Grafton, Wisconsin, has submitted a detailed public comment letter to the Centers for Medicare & Medicaid Services regarding the agency's proposed 2026 CMS Interoperability Standards and Prior Authorization for Drugs rule. In the letter, HealthLX outlines support for the rule's intent to extend electronic prior authorization for drugs and promote the adoption of Fast Healthcare Interoperability Resources standards under HIPAA, while offering practical recommendations to i more ST
Highlander Health Urges Food and Drug Administration to Advance AI Pilot Program for Early-Phase Clinical Trials (10)
WASHINGTON, July 3 -- Highlander Health, a healthcare innovation organization in New York, has expressed support for the Food and Drug Administration's initiative to launch an AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. Through a comprehensive public comment letter submitted to the FDA, Highlander Health outlined detailed recommendations aimed at enhancing the efficiency, decision quality, and regulatory robustness of early-phase clinical trials utilizing artificial intelligence technologies.
Highlander Health's submi more ST
Highmark Health Urges Centers for Medicare & Medicaid Services to Provide Clear Guidance and Support for Medicare and Medicaid Prior Authorization Changes (10)
WASHINGTON, July 3 -- Highmark Health, an integrated healthcare delivery and financing system in Pittsburgh, Pennsylvania, submitted a public comment letter to the Centers for Medicare & Medicaid Services regarding proposed rule. The rule addresses interoperability standards and prior authorization processes for Medicare Advantage Organizations, Medicaid managed care plans, state Medicaid agencies, Children's Health Insurance Program agencies and managed care entities, and qualified health plan issuers on the federally-facilitated exchanges.
H more ST
Hip Hop Caucus Calls for Stronger Environmental Protection Agency Standards on Hazardous Air Pollutants From Oil and Gas Facilities (10)
WASHINGTON, July 3 -- The Hip Hop Caucus submitted a public comment letter to the U.S. Environmental Protection Agency addressing the agency's proposed National Emission Standards for Hazardous Air Pollutants concerning crude oil and natural gas production, transmission, and storage facilities. The organization, which advocates for communities disproportionately impacted by pollution and environmental injustice, urged EPA to strengthen the final rule to better protect public health and address cumulative pollution burdens in frontline communiti more ST
HIV+Hepatitis Policy Institute Urges Stronger Prior Authorization Reforms for Critical Medications (10)
WASHINGTON, July 3 -- The HIV+Hepatitis Policy Institute has submitted a public comment letter to the U.S. Department of Health and Human Services Centers for Medicare & Medicaid Services addressing the agency's proposed rule on Interoperability Standards and Prior Authorization for Drugs. The Institute advocates for meaningful reforms to reduce prior authorization burdens that disproportionately impact people living with HIV, hepatitis, and other serious chronic diseases.
The Institute emphasizes that prior authorization (PA) protocols are fr more ST
HL7 Da Vinci Project Urges CMS to Support FHIR Standards and Flexible Implementation Timeline for Prior Authorization Rule (10)
WASHINGTON, July 3 -- The HL7 Da Vinci Project, a collaborative industry initiative headquartered in Ann Arbor, Michigan, addressed the Centers for Medicare & Medicaid Services with a public comment letter focusing on the agency's proposed rule concerning interoperability standards and prior authorization for drugs. The correspondence conveyed strong backing for the integration of HL7 Fast Healthcare Interoperability Resources implementation guides in facilitating data exchange among patients, providers, and payers, while recommending adjustmen more ST
Horizon Health Care Supports CMS Interoperability Standards to Improve Patient Access in South Dakota (10)
WASHINGTON, July 3 -- Horizon Health Care, Inc., a Federally Qualified Health Center based in Howard, South Dakota, has expressed support for the Centers for Medicare & Medicaid Services' 2026 proposed rule on interoperability standards and prior authorization for drugs. The nonprofit organization, which serves more than 26,000 patients annually across 19 rural and underserved communities in South Dakota, submitted a comprehensive public comment letter to CMS outlining both support for and recommendations on the rule's provisions.
The proposed more ST
Icahn School of Medicine Postdoctoral Fellow Calls for Withdrawal of Proposed Federal Rule on Research Funding (10)
WASHINGTON, July 3 -- Leo R. Zekelman, postdoctoral fellow at the Icahn School of Medicine, Mount Sinai, New York, has submitted a public comment letter to the U.S. Office of Management and Budget opposing the agency's proposed rule revising federal financial assistance regulations. The proposed rule aims to elevate the Uniform Guidance to binding regulations, adding provisions on political pre-issuance review, discretionary termination authority, international collaboration restrictions, diversity equity inclusion (DEI) limitations, and prohib more ST
Idaho Department of Environmental Quality Supports Environmental Protection Agency Proposal to Clarify New Source Review Construction Definitions (10)
WASHINGTON, July 3 -- The Idaho Department of Environmental Quality, Boise, has submitted a public comment letter to the U.S. Environmental Protection Agency regarding the agency's proposed rule to clarify the "begin actual construction" definition within the New Source Review preconstruction permitting program. IDEQ expressed support for the EPA's efforts to provide clearer guidance on preconstruction activities allowed before formal NSR permit issuance.
IDEQ's letter emphasized the importance of maintaining clarity around which activities fa more ST
Infusion Access Foundation Urges Centers for Medicare & Medicaid Services to Enhance Prior Authorization for Infusion Drugs (10)
WASHINGTON, July 3 -- The Infusion Access Foundation, Austin, Texas, submitted a public comment letter to the Centers for Medicare & Medicaid Services and the Office of the National Coordinator for Health Information Technology regarding the agencies' proposed rule on interoperability standards and prior authorization for drugs. The foundation advocates for patients with chronic, complex, and rare conditions dependent on specialty infusion and injection therapies.
The organization stresses that prior authorization often delays treatment and di more ST
Innovaccer Urges CMS to Strengthen Interoperability Standards for Prior Authorization in Healthcare (10)
WASHINGTON, July 3 -- Innovaccer, a San Francisco, California-based enterprise AI and data platform company, has submitted a public comment letter to the Centers for Medicare & Medicaid Services regarding the proposed rule on Interoperability Standards and Prior Authorization for Drugs. Innovaccer emphasized the need to move from recommended to required application of standardized healthcare data exchange protocols to streamline prior authorization processes for drugs across the healthcare system.
Innovaccer highlighted its extensive experienc more ST
International Association of Venue Managers Urges Federal Aviation Administration to Expand Drone Flight Restrictions for Wider Range of Event Venues (10)
WASHINGTON, July 3 -- The International Association of Venue Managers, Alexandria, Virginia, has provided a public comment letter to the Federal Aviation Administration regarding its proposed rule on unmanned aircraft flight restrictions near critical infrastructure facilities. The association, representing various public assembly venues such as arenas, convention centers, and amphitheaters, expressed concerns that the FAA's thresholds for applying these restrictions create security gaps, leaving many venues unprotected from drone-related threa more ST
International Cancer Advocacy Network Urges Centers for Medicare & Medicaid Services to Address Prior Authorization Delays for Biomarker Testing in Cancer Care (10)
WASHINGTON, July 3 -- The International Cancer Advocacy Network, Phoenix, Arizona, has submitted a public comment letter to the Centers for Medicare & Medicaid Services highlighting the detrimental effects of prior authorization requirements on timely access to laboratory biomarker testing for cancer patients. ICAN represents patients and families affected by late-stage and metastatic cancers and stresses that delays caused by prior authorization can hinder critical treatment decisions.
ICAN emphasized that biomarker testing is foundational to more ST
International Foodservice Distributors Association Urges Food and Drug Administration to Adjust Food Traceability Guidance to Ease Compliance Burdens (10)
WASHINGTON, July 3 -- The International Foodservice Distributors Association, McLean, Virginia, submitted a public comment letter to the U.S. Food and Drug Administration addressing the agency's draft guidance on additional traceability record requirements for certain foods under the FDA's food traceability rule. Representing the foodservice distribution industry, IFDA highlights operational challenges and proposes modifications to enhance compliance feasibility and maintain food safety objectives ahead of the rule's July 20, 2028, compliance d more ST
International Society for AI Standards in Biomedical Development Urges Focus on Governance in Food and Drug Administration AI Clinical Trial Pilot (10)
WASHINGTON, July 3 -- The International Society for AI Standards in Biomedical Development, Boston Massachusetts, submitted a public comment letter to the U.S. Food and Drug Administration supporting the agency's AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program while emphasizing important governance considerations. As a non-commercial initiative dedicated to AI governance in clinical trials and drug development, ISA-BMD highlighted underexplored areas including how AI influences decision-making, the role of override rates as more ST
Intertek Highlights Challenges and Solutions for Consumer Product Recall Fraud (10)
WASHINGTON, July 3 -- Intertek Testing Services NA Inc., Coral Springs, Florida, submitted a public comment letter to the U.S. Consumer Product Safety Commission addressing the ongoing challenge of consumer product recall fraud. Intertek, a global testing, inspection, and certification organization with expertise in clothing, footwear, toys, juvenile products, and furniture, emphasized the difficulty in linking specific recalled units or shipments to consumers, which creates vulnerabilities in recall verification processes.
Intertek outlined t more ST
Iota Intel Urges Centers for Medicare & Medicaid Services to Use Electronic Prior Authorization to Protect Vulnerable Patients (10)
WASHINGTON, July 3 -- Iota Intel LLC, a Frisco, Texas-based healthcare analytics firm, submitted a public comment letter to the U.S. Department of Health and Human Services Centers for Medicare & Medicaid Services addressing the proposed rule concerning interoperability standards and prior authorization for drugs. The letter offers extensive commentary aimed at enhancing the efficiency, transparency, and clinical relevance of electronic prior authorization processes affecting Medicare Advantage, Medicaid, the CHIP program, and Health Insurance more ST
Iowa Primary Care Association Urges Centers for Medicare & Medicaid Services to Enhance Interoperability and Prior Authorization Standards (10)
WASHINGTON, July 3 -- The Iowa Primary Care Association, Des Moines, Iowa, has submitted a public comment letter to the Centers for Medicare & Medicaid Services emphasizing the need to improve interoperability standards and prior authorization processes within Medicare Advantage Organizations, Medicaid managed care, and other federal health programs. The Iowa PCA advocates for reforms that would reduce administrative overhead and expedite patient access to needed medications and healthcare services, particularly for vulnerable populations serve more ST
IPWeb3 Urges Copyright Office to Prioritize Application Programming Interface Integration and Alternative Fee Structures (10)
WASHINGTON, July 3 -- IPWeb3 Zinkvision, London, England, submitted a public comment letter to the U.S. Copyright Office Library of Congress advocating for the development of an application programming interface for the Enterprise Copyright System Registration and proposing alternative fee structures. The company operates a blockchain-based intellectual property registration platform serving independent studios and media organizations globally.
The letter outlines that many small-to-mid-size creative studios, clients of IPWeb3, face challenges more ST
IQ Consortium Urges Inclusive AI Pilot Program to Optimize Early-Phase Clinical Trials (10)
WASHINGTON, July 3 -- The IQ Consortium, a nonprofit organization composed of pharmaceutical and biotechnology companies dedicated to advancing science and technology, has provided a comprehensive public comment letter to the U.S. Food and Drug Administration regarding the AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. The letter addresses multiple aspects of the pilot program design, implementation, evaluation metrics, success criteria, and collaboration models intended to harness artificial intelligence to improve clini more ST
Journal of Surveying Engineering Associate Editor Urges OMB to Withdraw Proposed 2 CFR Part 200 Revisions Threatening Grant Independence (10)
WASHINGTON, July 3 -- David A. Rolbiecki, associate editor for the Journal of Surveying Engineering, published by the American Society of Civil Engineers, has submitted a public comment letter to the Office of Management and Budget opposing the proposed overhaul of 2 CFR Part 200, which governs federal financial assistance. Rolbiecki argues that the transition from guidance to legally binding regulation would politicize grant-making, undermine scientific meritocracy, and jeopardize critical infrastructure resilience.
The comment warns that req more ST
Kansas Hospital Association Supports Centers for Medicare and Medicaid Services Efforts to Enhance Prior Authorization for Drugs (10)
WASHINGTON, July 3 -- The Kansas Hospital Association, Topeka, has expressed support for the Centers for Medicare and Medicaid Services proposed rule aimed at improving interoperability standards and prior authorization processes for drugs. The association, which represents 124 acute-care and community hospitals across Kansas, including critical access and rural emergency hospitals, appreciates CMS' work to foster transparency, beneficiary engagement, and reduction of administrative burdens.
The association welcomes CMS' initiatives to standar more ST
Kardigan Highlights Cardiovascular Data Advantages in Food and Drug Administration AI-Enabled Clinical Trials Pilot Feedback (10)
WASHINGTON, July 3 -- Kardigan, South San Francisco, California, and its subsidiary Prolaio submitted a public comment letter to the U.S. Food and Drug Administration outlining detailed feedback on the agency's AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. The submission responds to the FDA's Request for Information and addresses opportunities and challenges related to integrating artificial intelligence and digital biomarker data in clinical trial oversight, with an emphasis on cardiovascular disease applications.
Kard more ST
Kentucky Division for Air Quality Supports Enhancements to New Source Review Preconstruction Permitting Rules (10)
WASHINGTON, July 3 -- The Kentucky Division for Air Quality, part of the Energy and Environment Cabinet, Frankfort, submitted a public comment letter to the U.S. Environmental Protection Agency regarding its proposed revisions to the New Source Review Preconstruction Permitting Program. The Division expressed support for efforts to clarify and improve the consistency of NSR permitting requirements while urging the EPA to provide clear and specific regulatory language to ensure uniform application among permitting authorities.
The Division reco more ST
Labcorp Highlights Prior Authorization Challenges and Proposes Improvements for Laboratory Testing and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Items (10)
WASHINGTON, July 3 -- Laboratory Corp. of America Holdings, Burlington, North Carolina, has submitted a public comment letter to the Centers for Medicare & Medicaid Services outlining concerns and recommendations related to prior authorization requirements for laboratory testing and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies items. The letter responds to CMS's request for information on proposed interoperability standards aimed at improving prior authorization processes.
The company underscores that current prior authoriza more ST
Laboratory Associations Urge Centers for Medicare & Medicaid Services to Address Prior Authorization Barriers to Testing Access (10)
WASHINGTON, July 3 -- The American Association of Bioanalysts, Crystal City, Virginia, and the National Independent Laboratory Association, based in St. Louis, Missouri, submitted a public comment letter to the Centers for Medicare & Medicaid Services urging the agency to address the challenges posed by prior authorization requirements for clinical laboratory testing under Medicare. The associations, representing community and regional clinical laboratories nationwide, highlighted how prior authorizations delay patient care and increase adminis more ST
League of United Latin American Citizens Urges Accountability in Medicare and Medicaid Prior Authorization Modernization (10)
WASHINGTON, July 3 -- The League of United Latin American Citizens submitted a public comment letter to the Centers for Medicare & Medicaid Services expressing concerns and recommendations on the agency's proposed rule. This proposed rule aims to enhance interoperability standards and prior authorization procedures for Medicare, Medicaid, and other health programs to modernize electronic health information exchange and improve standardized denial communications.
As the nation's oldest and largest Latino civil rights organization representing o more ST
Legal Action Center Urges Stronger Prior Authorization Rules to Improve Access to Addiction Medications (10)
WASHINGTON, July 3 -- The Legal Action Center, New York, has submitted a public comment letter to the U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services. The letter addresses the proposed rule on Interoperability Standards and Prior Authorization for Drugs applicable to Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Children's Health Insurance Program Agencies and Managed Care Entities, and issuers of Qualified Health Plans on federally-facilitated exchanges.
The org more ST
LifeProtect Urges Clearer Regulatory Pathway for Reusable Respirators (10)
WASHINGTON, July 3 -- LifeProtect LLC, Surfside, Florida, submitted a public comment letter to the U.S. Food and Drug Administration regarding its draft guidance on compliance policies for certain NIOSH approved air-purifying respirators. As a holding company with subsidiaries engaged in producing FDA, NIOSH, and Health Canada approved masks and advanced antimicrobial PPE, LifeProtect supports FDA's efforts to improve regulatory efficiency but calls for clearer pathways for reusable antimicrobial respirators.
LifeProtect emphasizes that the re more ST
Louisville Gas & Electric and Kentucky Utilities Urge Environmental Protection Agency to Refine Coal Combustion Residuals Regulations to Enhance Beneficial Use and State Authority (10)
WASHINGTON, July 3 -- Louisville Gas and Electric Co. and Kentucky Utilities Co., Louisville, Kentucky, have submitted public comments to the U.S. Environmental Protection Agency regarding the agency's proposed amendments to the Hazardous and Solid Waste Management System for Disposal of Coal Combustion Residuals from Electric Utilities, particularly addressing the Legacy CCR Management Units provisions. The companies, which operate multiple coal-fired generating stations, stressed their support for regulatory efforts that balance environmental more ST
Loyola University Chicago Professor Gallagher Urges OMB to Withdraw Proposed Rule Threatening Peer Review and Financial Assistance Guidance (10)
WASHINGTON, July 3 -- Thomas M Gallagher, professor of microbiology and immunology at Loyola University Chicago, Illinois, has submitted a public comment letter to the U.S. Office of Management and Budget opposing a proposed rule revising federal financial assistance regulations. The letter addresses concerns about provisions that could transform the Uniform Guidance from flexible policy into binding regulation, potentially imposing disproportionate costs on smaller and underrepresented research institutions.
The scientist highlights key issue more ST
Lundbeck Pharmaceuticals Urges Centers for Medicare and Medicaid Services To Adopt Uniform 24-Hour Prior Authorization for Drugs (10)
WASHINGTON, July 3 -- Lundbeck Pharmaceuticals LLC, Deerfield, Illinois, provided its public comment letter to the Centers for Medicare and Medicaid Services regarding the agency's proposed rule on interoperability standards and prior authorization for drugs affecting Medicare Advantage Organizations, Medicaid managed care plans, Children's Health Insurance Program agencies, and issuers of qualified health plans on federally-facilitated exchanges. The proposed rule aims to promote electronic exchange of healthcare information and streamline pri more ST
Lupus and Allied Diseases Association Urges Medicare and Medicaid Service Reforms on Step Therapy Protocols (10)
WASHINGTON, July 3 -- The Lupus and Allied Diseases Association Inc., Verona, New York, has submitted a public comment letter to the Centers for Medicare & Medicaid Services expressing concerns about the use of step therapy, also known as fail-first protocols, in drug prior authorization processes. The patient-led organization advocates for reforms to ensure timely and appropriate access to treatments for individuals managing lupus and other complex autoimmune diseases.
The association, representing patients and their families, highlighted tha more ST
Main Street Foundation Urges Environmental Protection Agency to Reassess Methylene Chloride Reporting Requirements Under Toxic Substances Control Act (10)
WASHINGTON, July 3 -- The Main Street Foundation has submitted a public comment letter expressing concerns to the U.S. Environmental Protection Agency regarding the renewal of the Information Collection Request related to methylene chloride regulations under Section 6(a) of the Toxic Substances Control Act. The letter critiques the Environmental Protection Agency's approach to consolidating paperwork requirements and highlights the potential for duplicated regulatory burdens on businesses, especially small entities.
The Main Street Foundation' more ST
Maine Primary Care Association Highlights Challenges and Supports Centers for Medicare & Medicaid Services Proposals to Streamline Prior Authorization and Enhance Interoperability (10)
WASHINGTON, July 3 -- The Maine Primary Care Association, Augusta, Maine, expressed support for the Centers for Medicare & Medicaid Services proposed rule aimed at improving interoperability standards and prior authorization processes for Medicare Advantage Organizations, Medicaid Managed Care Plans, and other healthcare entities. In a comprehensive public comment letter submitted to CMS, the association underscored the significant administrative burdens and treatment delays experienced by community health centers also known as Federally Qualif more ST
Maryland Department of Health Raises Concerns Over Centers for Medicare and Medicaid Services Proposed Interoperability and Prior Authorization Rule (10)
WASHINGTON, July 3 -- The Maryland Department of Health, Baltimore, submitted a public comment letter to the Centers for Medicare and Medicaid Services regarding the agency's 2026 proposed rule on Interoperability Standards and Prior Authorization for Drugs. The department expressed concerns about the operational feasibility, technical challenges, and compliance timelines outlined in the proposal, asking CMS to reconsider or clarify several provisions.
The CMS proposed rule seeks to expand interoperability requirements and prior authorization more ST
Massachusetts Health Data Consortium Calls for Extended Timelines and Stronger Standards in Centers for Medicare and Medicaid Services Prior Authorization Rule (10)
WASHINGTON, July 3 -- The Massachusetts Health Data Consortium, Cambridge, has submitted a public comment letter to the Centers for Medicare and Medicaid Services addressing the agency's proposed rule on Medicare and Medicaid programs focusing on interoperability standards and prior authorization for drugs across Medicare Advantage, Medicaid Managed Care Plans, CHIP Agencies, and Qualified Health Plans. In its letter, MHDC emphasizes the need for clearer operational guidelines, extended compliance timelines, and industry-aligned standards adopt more ST
McKesson Urges Centers for Medicare & Medicaid Services to Strengthen Electronic Prior Authorization and Interoperability Standards for Prescription Drugs (10)
WASHINGTON, July 3 -- McKesson Corp., Irving, Texas, has expressed support for the U.S. Centers for Medicare & Medicaid Services' proposed rule aimed at enhancing interoperability standards and electronic prior authorization processes for prescription drugs. In a public comment letter submitted to CMS, McKesson emphasized the importance of modernizing healthcare data exchange to reduce administrative burdens and accelerate patient access to medications. The letter urges the agency to incorporate real-world workflows across the healthcare ecosys more ST
Medable Proposes AI-Driven Solutions for Food and Drug Administration's Early-Phase Clinical Trials Pilot Program (10)
WASHINGTON, July 3 -- Medable, a clinical trial technology company in Palo Alto, California, has submitted a comprehensive public comment letter to the U.S. Food and Drug Administration regarding the AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. The letter outlines detailed recommendations on pilot design, participant selection, collaboration, operational infrastructure, evaluation metrics, and governance structures aimed at enhancing the efficiency and quality of early-phase clinical trials through artificial intelligen more ST
Medicaid and CHIP Payment and Access Commission Urges Greater Transparency and Data Reporting in CMS Prior Authorization Rule (10)
WASHINGTON, July 3 -- The Medicaid and CHIP Payment and Access Commission provided public comment to the Centers for Medicare & Medicaid Services regarding its proposed rule on interoperability standards and prior authorization for prescription drugs under Medicaid, the Children's Health Insurance Program, Medicare Advantage organizations, and qualified health plans on federally-facilitated exchanges. The rulemaking, issued by the U.S. Department of Health and Human Services, aims to enhance data exchange and transparency in prior authorization more ST
Medicaid Community Engagement Rule May Limit Access to Treatment at For-Profit Opioid Programs (10)
WASHINGTON, July 3 -- Genesis Treatment Services, Baltimore, Maryland, submitted a public comment letter urging the Centers for Medicare and Medicaid Services to reconsider provisions within the Medicaid program's Community Engagement Requirements. The letter addresses the Interim Final Rule, raising concerns that current interpretation could restrict access to opioid use disorder treatments for Medicaid beneficiaries receiving care at licensed for-profit Opioid Treatment Programs.
Genesis Treatment Services, a Maryland-licensed opioid treatme more ST
Medicaid Health Plans of America Urges Delay in CMS Prior Authorization Drug API Implementation (10)
WASHINGTON, July 3 -- The Medicaid Health Plans, Arlington, Virginia, addressed the U.S. Department of Health and Human Services Centers for Medicare & Medicaid Services in a public comment letter concerning the agency's proposed 2026 Interoperability Standards and Prior Authorization for Drugs rule. Representing over 160 Medicaid managed care organizations serving nearly 47 million Medicaid enrollees across 40 states, the District of Columbia, and Puerto Rico, MHPA expressed support for CMS's aims to enhance the prior authorization process to more ST
Medical Group Management Association Urges Centers for Medicare & Medicaid Services to Strengthen Prior Authorization Reforms (10)
WASHINGTON, July 3 -- The Medical Group Management Association, Englewood, Colorado, has submitted a public comment letter to the Centers for Medicare & Medicaid Services concerning the agency's proposed rule on interoperability standards and prior authorization for drugs affecting Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Children's Health Insurance Program entities, and issuers of Qualified Health Plans on Federally-Facilitated Exchanges. MGMA, representing over 15,000 medical groups and more than more ST
Medicare Rights Center Urges Enhanced Transparency and Safeguards in Medicare Interoperability Rule (10)
WASHINGTON, July 3 -- The Medicare Rights Center, a nonprofit organization in New York, submitted a public comment letter to the Centers for Medicare & Medicaid Services regarding proposed updates to interoperability standards and prior authorization processes for drugs under Medicare Advantage, Medicaid, CHIP, and federally facilitated exchange plans. The letter addressed the proposed rule and highlighted the organization's sustained commitment to ensuring access to affordable healthcare for older adults and people with disabilities.
The Medi more ST
Medidata Proposes Strategic Framework to Support Food and Drug Administration AI-Enabled Early-Phase Clinical Trial Pilot Program (10)
WASHINGTON, July 3 -- Medidata Solutions, a clinical data and analytics company in New York, has submitted a comprehensive public comment letter to the U.S. Food and Drug Administration outlining its recommendations and readiness to support the agency's AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. The company emphasized its capability to align with the FDA's ambitious timeline and regulatory goals for accelerating early-phase clinical research through real-time data integration and AI technologies.
The letter presented more ST
Mercy Raises Concerns Over Centers for Medicare and Medicaid Services Proposed Medicaid Payment Rule (10)
WASHINGTON, July 3 -- Mercy, a multi-state health care system headquartered in St. Louis, Missouri, has submitted a public comment letter to the Centers for Medicare and Medicaid Services regarding the proposed rule on Medicaid Managed Care State Directed Payments and Medicaid Fee-for-Service Targeted Medicaid Practitioner Payments. Mercy emphasizes that while it supports the agency's goals for transparency and accountability, the proposal contains provisions that exceed statutory authority, diverge from traditional Medicaid policy, and may jeo more ST
Mindful Choices for ADHD Urges Centers for Medicare & Medicaid Services to Strengthen ADHD Medication Prior Authorization Policies (10)
WASHINGTON, July 3 -- Mindful Choices for ADHD, a nonprofit organization in New York, has submitted a public comment letter to the Centers for Medicare & Medicaid Services expressing support for the agency's efforts to streamline prior authorization and enhance interoperability in drug approvals, while urging stronger protections for individuals with Attention Deficit Hyperactivity Disorder. The letter addresses CMS's proposed rule concerning Medicare and Medicaid programs, as well as health plans on federally-facilitated exchanges, emphasizing more ST
Minnesota Pollution Control Agency Urges Environmental Protection Agency to Withdraw Proposed Revisions to New Source Review Construction Rules (10)
WASHINGTON, July 3 -- The Minnesota Pollution Control Agency, St. Paul, expressed opposition in a public comment letter to the U.S. Environmental Protection Agency regarding the agency's proposed rule revising the definition of "begin actual construction" under the New Source Review preconstruction permitting program. The letter emphasized concerns about regulatory certainty, rule clarity, program effectiveness, public trust, and consistency among states.
The MPCA criticized the EPA proposal for reducing regulatory certainty by creating ambigu more ST
Minnkota Power Cooperative Urges Environmental Protection Agency to Rescind Coal Combustion Residuals Management Unit Requirements (10)
WASHINGTON, July 3 -- Minnkota Power Cooperative, Grand Forks, North Dakota, submitted a public comment letter to the U.S. Environmental Protection Agency regarding the agency's proposed amendments to the coal combustion residuals regulations, specifically addressing the Legacy Coal Combustion Residuals Management Unit provisions. The cooperative, which operates the lignite coal-fired Milton R. Young Station in Center, North Dakota, articulated support for EPA's proposal to revise the 2024 Legacy CCR Rule and called for the full rescission of C more ST
Miss. Office of Capital Post-Conviction Counsel Warns Department of Justice that Mississippi's Capital Appeal Proposal Creates Unattainable Deadlines (10)
WASHINGTON, July 3 -- The Mississippi Office of Capital Post-Conviction Counsel, Jackson, expressed opposition to the Mississippi Attorney General's application for certification under Chapter 154 of the Antiterrorism and Effective Death Penalty Act in a recent public comment letter submitted to the U.S. Department of Justice. The CPCC, responsible for representing indigent inmates sentenced to death during post-conviction proceedings, highlighted multiple systemic issues hindering effective legal representation, particularly noting the impract more ST
Montana-Dakota Utilities Advocates for Rescission and Flexibility in Environmental Protection Agency Coal Ash Disposal Rules (10)
WASHINGTON, July 3 -- Montana-Dakota Utilities Co., Bismarck, North Dakota, submitted a public comment letter to the U.S. Environmental Protection Agency regarding the agency's proposed revisions to regulations governing the disposal of coal combustion residuals from electric utilities. Montana-Dakota addresses the agency's April 2026 proposal to amend the federal CCR rules, including the potential rescission of the Coal Combustion Residual Management Unit requirements and various adjustments to groundwater monitoring, closure protocols, and be more ST
Motion Picture Association Supports Exploring Alternative Fee Structures for Copyright Registration (10)
WASHINGTON, July 3 -- The Motion Picture Association Inc. has submitted a public comment letter to the U.S. Copyright Office regarding its Notice of Inquiry on Alternative Fee Structures for Registration. The association, representing major film, television, and streaming companies such as Amazon Studios LLC and Netflix Studios LLC, expressed support for efforts to modernize copyright registration fees to improve accessibility and efficiency.
The association acknowledges the importance of ensuring the Copyright Office is sufficiently funded to more ST
MultiCare Health System Highlights Implementation Risks in Drug Prior Authorization Proposal (10)
WASHINGTON, July 3 -- MultiCare Health System, Tacoma, Washington state, submitted a public comment letter to the U.S. Department of Health and Human Services Centers for Medicare & Medicaid Services addressing the Interoperability Standards and Prior Authorization for Drugs proposed rule. While the health system supports the rule's intent to reduce administrative burden, it raised concerns about operational, technical, and financial risks tied to implementing the proposal.
MultiCare emphasized significant challenges related to increased compl more ST
Myriad Genetics Requests Centers for Medicare and Medicaid Services to Curb Prior Authorization Barriers in Medicare Advantage for Laboratory Tests (10)
WASHINGTON, July 3 -- Myriad Genetics, a molecular diagnostic laboratory in Salt Lake City, Utah, submitted a public comment letter to the Centers for Medicare & Medicaid Services addressing concerns about prior authorization practices imposed by Medicare Advantage organizations on laboratory tests covered under National Coverage Determinations and Local Coverage Determinations. The genetic testing company emphasized the burdens these practices place on healthcare providers and beneficiaries, calling for regulatory action to alleviate such obst more ST
N.H. Hospital Association Urges Centers for Medicare & Medicaid Services to Enhance Prior Authorization for Drugs (10)
WASHINGTON, July 3 -- The New Hampshire Hospital Association, Concord, submitted a public comment letter to the Centers for Medicare & Medicaid Services expressing support for the agency's proposed rule aimed at improving interoperability and streamlining prior authorization for drugs under Medicare Advantage, Medicaid, Children's Health Insurance Program, and Qualified Health Plans on federally facilitated exchanges.
NHHA emphasizes the daily impact of fragmented prior authorization procedures on hospitals and health systems in New Hampshire, more ST
N.J. Department of Environmental Protection Highlights Gaps in Environmental Protection Agency PFAS Disposal Guidance (10)
WASHINGTON, July 3 -- The New Jersey Department of Environmental Protection, Trenton, has submitted a public comment letter to the U.S. Environmental Protection Agency addressing the "Interim Guidance on the Destruction and Disposal of Perfluoroalkyl and Polyfluoroalkyl Substances and Materials Containing Perfluoroalkyl and Polyfluoroalkyl Substances - 2026 Version." The NJDEP appreciates the agency's ongoing efforts to update guidance on per- and polyfluoroalkyl substances destruction and disposal but notes that key challenges and data gaps re more ST
Natera Calls for Reforms to Prior Authorization Policies Impacting Laboratory Testing (10)
WASHINGTON, July 3 -- Natera, a diagnostics company in San Carlos, California, submitted a public comment letter to the Centers for Medicare & Medicaid Services regarding pending regulations on laboratory tests and durable medical equipment, prosthetics, orthotics, and supplies. The letter focuses on the burdens and patient impacts of prior authorization requirements imposed by Medicare Advantage and other payer programs on laboratory testing.
Natera highlights that timely access to laboratory tests, particularly molecular and genetic testing more ST
National Association of Chain Drug Stores Highlights Pharmacy Integration in Centers for Medicare and Medicaid Services Interoperability Rule (10)
WASHINGTON, July 3 -- The National Association of Chain Drug Stores, Arlington, Virginia, issued a public comment letter addressing the Centers for Medicare & Medicaid Services' proposed rule on interoperability standards and prior authorization for drugs. NACDS emphasized the importance of pharmacy integration within the CMS rule to ensure electronic prior authorization processes effectively reduce administrative burdens and improve patient access.
In the letter submitted to the CMS under the Department of Health and Human Services, NACDS sup more ST
National Association of Community Health Centers Urges Centers for Medicare & Medicaid Services to Improve Prior Authorization and Interoperability Standards (10)
WASHINGTON, July 3 -- The National Association of Community Health Centers, has submitted a public comment letter to the U.S. Department of Health and Human Services Centers for Medicare & Medicaid Services addressing proposed changes to Medicare and Medicaid interoperability standards and prior authorization processes for prescription drugs and other services. The NACHC emphasized the importance of reducing administrative burdens and expediting patient access to care for the 52 million patients served annually by community health centers acros more ST
National Association of Manufacturers Supports Environmental Protection Agency Delay of Tier 4 Vehicle Emissions Standards (10)
WASHINGTON, July 3 -- The National Association of Manufacturers has expressed support for the U.S. Environmental Protection Agency's proposed two-year delay in the Tier 4 criteria pollutant standards compliance deadline for light-duty and medium-duty vehicles. In a public comment letter, the NAM highlights the importance of realistic regulatory timelines and the need for policies that balance environmental stewardship with manufacturing sector growth.
The association acknowledges the EPA's commitment to workable regulations but emphasizes that more ST
National Association of Manufacturers Supports Environmental Protection Agency Proposal to Clarify Construction Start Rules in NSR Program (10)
WASHINGTON, July 3 -- The National Association of Manufacturers, Arlington, Virginia, submitted a public comment letter to the U.S. Environmental Protection Agency regarding its proposed revision to the definition of "begin actual construction" under the Clean Air Act's New Source Review Preconstruction Permitting Program. NAM expressed support for the agency's effort to clarify permitting procedures that allow manufacturers to start construction of non-emitting infrastructure components prior to receiving NSR permits.
NAM emphasized that the more ST
National Association of Medicaid Directors Urges Centers for Medicare and Medicaid Services to Extend Timeline for Drug Prior Authorization Interoperability Rule (10)
WASHINGTON, July 3 -- The National Association of Medicaid Directors, representing state Medicaid leaders nationwide, has submitted a public comment letter to the Centers for Medicare and Medicaid Services regarding the agency's proposed 2026 Interoperability Standards and Prior Authorization for Drugs rule. The letter expresses concerns about the feasibility of meeting the rule's implementation requirements within the proposed timelines and urges CMS to provide additional support to Medicaid agencies managing complex system and policy changes. more ST
National Community Pharmacists Association Supports Centers for Medicare & Medicaid Services Drug Prior Authorization Standards With Implementation Concerns (10)
WASHINGTON, July 3 -- The National Community Pharmacists Association, Alexandria, Virginia, has submitted a public comment letter to the Centers for Medicare & Medicaid Services regarding proposed interoperability standards and prior authorization rules for drugs within Medicare Advantage Organizations, Medicaid, CHIP programs, and Qualified Health Plans on federally-facilitated exchanges. NCPA represents 18,900 independent community pharmacies nationwide and advocates for policies that address the operational realities faced by community and l more ST
National Consumer Law Center Seeks Updates to Income-Driven Repayment Plan Request Form (10)
WASHINGTON, July 3 -- The National Consumer Law Center, Boston, Massachusetts, has submitted a public comment letter to the U.S. Department of Education regarding proposed revisions to the Income-Driven Repayment Plan Request Form. The organization advocates for borrowers of all income levels, especially low-income clients, and draws attention to necessary corrections in the form and associated loan processing systems to align with new repayment regulations going into effect July 1, 2026.
The letter emphasizes the need to update definitions an more ST
National Council for Prescription Drug Programs Supports Centers for Medicare & Medicaid Services Adoption of Electronic Prior Authorization Standards (10)
WASHINGTON, July 3 -- The National Council for Prescription Drug Programs Inc., Scottsdale, Arizona, has submitted a public comment letter to the U.S. Department of Health and Human Services Centers for Medicare & Medicaid Services. The letter addresses a proposed rule to adopt standards supporting electronic prior authorization, formulary and benefit information exchange, and real-time prescription benefit transactions for drugs covered under pharmacy benefits.
The National Council for Prescription Drug Programs (NCPDP) represents more than 1 more ST
National Drug and Alcohol Screening Association Supports Food and Drug Administration Expansion of Device Exemptions for Workplace Drug Testing (10)
WASHINGTON, July 3 -- The National Drug and Alcohol Screening Association expressed support in a public comment letter to the Food and Drug Administration for the agency's plan to expand premarket notification exemptions under section 510(k) for certain medical devices used in workplace drug testing. NDASA praises the move as it will reduce regulatory burdens on manufacturers and eliminate costs associated with 510(k) submissions for some devices.
NDASA explains in the letter that federally mandated workplace drug testing programs under the De more ST
National Electrical Manufacturers Association Submits Public Comment to Consumer Product Safety Commission Warning of Dangerous Counterfeit Electrical Products (10)
WASHINGTON, July 3 -- The National Electrical Manufacturers Association, Rosslyn, Virginia, submitted a public comment letter to the U.S. Consumer Product Safety Commission addressing the widespread issue of counterfeit certification markings on electrical products. Representing over 300 manufacturers contributing significantly to the U.S. economy, NEMA highlighted the prevalence of fake certification marks on items such as power cords, extension cords, circuit breakers, lighting products, ceiling fans, charging equipment, and small appliances. more ST
National Fisheries Institute Requests Clarifications on Food and Drug Administration Seafood Traceability Guidance (10)
WASHINGTON, July 3 -- The National Fisheries Institute, Arlington, Virginia, submitted a public comment letter to the U.S. Food and Drug Administration regarding the Draft Guidance for Industry on additional traceability records for certain foods. As the largest commercial seafood trade association in the United States, NFI represents diverse sectors of the seafood supply chain, including harvesters, processors, and importers.
The letter highlights multiple areas where NFI seeks further clarification and confirmation from the agency. First, NF more ST
National Grocers Association Seeks Greater Flexibility in Food and Drug Administration Food Traceability Guidance (10)
WASHINGTON, July 3 -- The National Grocers Association, Arlington, Virginia, submitted a public comment letter to the U.S. Food and Drug Administration addressing the agency's Draft Guidance on the Food Traceability Rule. The letter reflects independent community grocers' concerns and suggestions regarding the implementation of additional traceability record requirements for certain foods, aiming to reduce operational burdens while maintaining food safety.
The association welcomed the FDA's extension of the compliance date to July 20, 2028, an more ST
National Health Council Urges Refinements in Centers for Medicare & Medicaid Services Interoperability and Prior Authorization Proposal (10)
WASHINGTON, July 3 -- The National Health Council has submitted a public comment letter to the Centers for Medicare & Medicaid Services regarding the agency's proposed rule addressing interoperability standards and prior authorization processes for drugs within Medicare Advantage, Medicaid, CHIP, and Qualified Health Plans on the Federally-Facilitated Exchanges. The council, representing nearly 200 national health-related organizations including patient groups, providers, researchers, caregivers, biopharmaceuticals, and payers, outlined their p more ST
National Industries for the Blind Calls for Withdrawal of Proposed Fee and Contracting Rule Changes by AbilityOne Commission (10)
WASHINGTON, July 3 -- National Industries for the Blind, Alexandria, Virginia, submitted a public comment letter to the U.S. AbilityOne Commission regarding the Commission's proposed rule revising central nonprofit agencies' requirements related to fee charges and subcontracting permissions within the AbilityOne Program. The AbilityOne Commission oversees the AbilityOne Program, which facilitates employment opportunities for people who are blind or severely disabled by distributing federal government procurement contracts to qualified nonprofit more ST
National League of Cities Urges Department of Justice to Ease Accessibility Compliance Burdens on Local Governments (10)
WASHINGTON, July 3 -- The National League of Cities, representing over 19,000 cities, towns, and villages, has submitted a public comment letter to the U.S. Department of Justice regarding the interim final rule on the extension of compliance dates for nondiscrimination based on disability and accessibility of web information and services of state and local government entities. The letter outlines concerns about the financial, technical, and operational challenges faced by local governments, particularly smaller municipalities, in meeting the r more ST
National Multiple Sclerosis Society Urges Centers for Medicare and Medicaid Services to Enhance Prior Authorization Processes for MS Treatments (10)
WASHINGTON, July 3 -- The National Multiple Sclerosis Society has submitted a public comment letter to the Centers for Medicare & Medicaid Services advocating for improvements in the agency's proposed rule regarding interoperability standards and prior authorization for drugs under Medicare Advantage, Medicaid, CHIP, and qualified health plans on the federally-facilitated exchanges. The Society emphasized the challenges faced by individuals with multiple sclerosis and highlighted the urgent need for CMS to ensure that prior authorization proces more ST
National Music Publishers Advocate for Balanced Copyright Office Fee Structures (10)
WASHINGTON, July 3 -- The National Music Publishers' Association has provided detailed feedback to the U.S. Copyright Office responding to its Notice of Inquiry regarding Alternative Fee Structures for Registration. Representing a broad spectrum of the music publishing and songwriting industry, the association emphasizes the need for fee models that encourage wide participation without increasing costs or eliminating current registration options.
The association highlights that music publishers and songwriters are among the most frequent users more ST
National Press Photographers Association Advocates For Subscription-Based Copyright Registration Model (10)
WASHINGTON, July 3 -- The National Press Photographers Association, Athens, Georgia, submitted a public comment letter to the U.S. Copyright Office regarding the agency's inquiry into alternative fee structures for copyright registration. NPPA represents thousands of visual journalists, including staff photographers, freelancers, and independent publishers, and they support fee structures that promote greater participation and administrative efficiency.
NPPA emphasized that photographers face substantial barriers to copyright registration, not more ST
National Ready Mixed Concrete Association Urges Environmental Protection Agency to Support Beneficial Use of Fly Ash in Concrete and Clarify Coal Combustion Residuals Regulations (10)
WASHINGTON, July 3 -- The National Ready Mixed Concrete Association, Alexandria, Virginia, has submitted a public comment letter to the U.S. Environmental Protection Agency regarding the agency's proposed amendments to the Hazardous and Solid Waste Management System for the disposal of coal combustion residuals from electric utilities. The letter addresses the April 2026 proposal focusing on legacy CCR management units and beneficial use definitions.
NRMCA, representing over 2,250 companies and subsidiaries that employ more than 135,000 worker more ST
National Restaurant Association Seeks Clarifications on Food and Drug Administration Food Traceability Guidance (10)
WASHINGTON, July 3 -- The National Restaurant Association submitted a public comment letter to the U.S. Food and Drug Administration regarding the agency's draft guidance on additional traceability requirements for certain foods. The Association highlighted several areas needing clarification to help restaurant operators comply with the FDA's final traceability rule published in 2022.
The Association emphasized the need for clearer FDA expectations on the minimum Key Data Elements (KDEs) required when full data collection is not feasible for r more ST
National Society of Genetic Counselors Highlights Impact of Prior Authorization on Patient Care and Provider Burden (10)
WASHINGTON, July 3 -- The National Society of Genetic Counselors, Chicago, Illinois, submitted a public comment letter to the U.S. Department of Health and Human Services Centers for Medicare & Medicaid Services addressing concerns about prior authorization requirements for laboratory tests, particularly genetic testing. The organization detailed how current prior authorization processes can negatively affect patient care and contribute to administrative burdens on healthcare providers.
NSGC emphasized that unjustified prior authorization mand more ST
National Wildlife Federation Urges Environmental Protection Agency to Withdraw Proposed Rule on Preconstruction Activity (10)
WASHINGTON, July 3 -- The National Wildlife Federation, Reston, Virginia, submitted a public comment letter to the U.S. Environmental Protection Agency expressing opposition to the agency's proposed rule revision titled "Begin Actual Construction in the New Source Review Preconstruction Permitting Program." The conservation organization warns that the revision would allow companies to commence significant construction activities before completing the rigorous New Source Review permit process, potentially jeopardizing public health, particularly more ST
National Writers Union Urges Copyright Office to Create Easier Registration for Web Content (10)
WASHINGTON, July 3 -- The National Writers Union, New York, has submitted a public comment letter to the U.S. Copyright Office in response to its Notice of Proposed Rulemaking regarding group registration of updates to a news website. The NWU, an independent national labor union representing freelance and contract writers and media workers, expressed concerns about current copyright registration procedures and petitioned for a more accessible process tailored to online content creators.
The NWU highlighted the proposed rule's expansion of the more ST
NeoGenomics Laboratories Urges Centers for Medicare & Medicaid Services to Reform Prior Authorization Processes for Laboratory Tests (10)
WASHINGTON, July 3 -- NeoGenomics Laboratories Inc., Fort Myers, Florida, has submitted a public comment letter to the Centers for Medicare & Medicaid Services regarding the agency's Request for Information on prior authorization requirements for clinical laboratory tests. NeoGenomics, a provider of diagnostics serving oncology and hematology providers among others, highlighted the challenges that existing prior authorization procedures pose to timely patient care and laboratory operations.
NeoGenomics stressed that clinical laboratory service more ST
New Jersey Reentry Urges Centers for Medicare & Medicaid Services to Clarify Medicaid Community Engagement Rules for Justice-Involved Individuals (10)
WASHINGTON, July 3 -- The New Jersey Reentry Corp., a nonprofit in Jersey City, New Jersey, has submitted a public comment letter to the Centers for Medicare & Medicaid Services regarding the interim final rule on Medicaid community engagement requirements for certain individuals. The organization, which serves approximately 35,000 returning citizens and veterans annually, focused its remarks on the operational treatment of individuals transitioning from incarceration under the community engagement rule.
The New Jersey Reentry Corporation advo more ST
New York Attorney General Seeks Extension for FAA Drone Regulation Comments (10)
WASHINGTON, July 3 -- The New York Attorney General has submitted a public comment letter to the Federal Aviation Administration regarding the agency's proposed rulemaking on restricting unmanned aircraft operations near fixed site facilities. The letter requests a 30-day extension beyond the July 6, 2026 deadline to allow more thorough evaluation and interagency coordination on the proposed regulations.
The New York Attorney General's Office highlighted critical concerns related to the proposed unmanned aircraft flight restriction process und more ST
New York State Department of Environmental Conservation Opposes Environmental Protection Agency Proposal on Construction Permitting Rules (10)
WASHINGTON, July 3 -- The New York State Department of Environmental Conservation, Albany, has submitted a public comment letter to the U.S. Environmental Protection Agency regarding the agency's proposed revisions to the New Source Review preconstruction permitting program. The DEC opposes the EPA's changes, calling them unnecessary and harmful.
The DEC argues that the proposed definition of "begin actual construction" lacks clarity and could lead to inconsistent interpretations across states, potentially undermining the Clean Air Act's permi more ST
NexTrial.ai Proposes Verification Framework for AI-Assisted Clinical Trial Decisions (10)
WASHINGTON, July 3 -- NexTrial.ai, New York, has submitted a public comment letter to the U.S. Food and Drug Administration outlining a new regulatory validation framework designed to enhance trustworthiness and compliance in AI-assisted clinical trial activation decisions. This framework aims to address current gaps in how AI systems are validated when they assist or automate regulatory drafting, patient eligibility assessments, and multi-jurisdictional compliance coordination across clinical trial sites.
The company proposes a novel architec more ST
North Olympic Healthcare Network Urges CMS to Support Interoperability and Prior Authorization Reforms to Enhance Patient Care (10)
WASHINGTON, July 3 -- North Olympic Healthcare Network, Port Angeles, Washington state, has expressed support for the Centers for Medicare & Medicaid Services' proposed rule on interoperability standards and prior authorization for drugs, while outlining key concerns and recommendations to ensure effective implementation. The community health center, which provides comprehensive healthcare services to more than 19,000 patients in medically underserved communities, submitted a public comment letter addressing how the rule's provisions could impa more ST
Northern Kentucky Water District Advocates for Water Infrastructure Protections Under Federal Aviation Administration Proposed Rule (10)
WASHINGTON, July 3 -- Northern Kentucky Water District, Erlanger, submitted a public comment letter to the Federal Aviation Administration regarding the proposed 14 CFR Part 74 rule addressing the Water and Wastewater Systems Sector under Sec. 74.96. NKWD expressed support for the proposal and urged the FAA to develop clear eligibility criteria to designate unmanned aircraft flight restrictions for the sector.
NKWD emphasized including facility types such as water treatment plants, elevated storage tanks or water towers, pump stations with ope more ST
OCHIN Urges Centers for Medicare & Medicaid Services to Tailor Drug Prior Authorization Implementation for Rural and Low-Resourced Providers (10)
WASHINGTON, July 3 -- OCHIN, Portland, Oregon, submitted a public comment letter to the Centers for Medicare & Medicaid Services regarding the agency's proposed rule on interoperability standards and prior authorization for drugs under Medicare Advantage, Medicaid Managed Care, CHIP, and federally-facilitated exchanges. The organization emphasized the importance of aligning implementation timelines and support with the unique challenges faced by rural and low-resourced providers such as Federally Qualified Health Centers, Critical Access Hospit more ST
OmniScience Advocates for Food and Drug Administration Pilot Program to Accelerate Early-Phase Clinical Trials Using AI (10)
WASHINGTON, July 3 -- OmniScience, a clinical trial technology company in Redwood City, California, has submitted a public comment letter to the U.S. Food and Drug Administration supporting the agency's initiative to leverage artificial intelligence to optimize early-phase clinical trials. The letter addresses FDA's Request for Information on the "AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program" and outlines recommendations intended to modernize clinical development, shorten timelines, reduce costs, and get more medicines t more ST
Osceola Community Health Services Urges Centers for Medicare & Medicaid Services to Improve Prior Authorization and Interoperability Standards to Benefit Medically Underserved Patients (10)
WASHINGTON, July 3 -- Osceola Community Health Services, Kissimmee, Florida, has submitted a public comment letter to the Centers for Medicare & Medicaid Services addressing proposed changes to Medicare and Medicaid programs under the Patient Protection and Affordable Care Act. The letter provides detailed feedback on CMS' 2026 Interoperability Standards and Prior Authorization for Drugs Proposed Rule, emphasizing the need to reduce administrative burdens and improve timely access to care and medications for underserved populations served by co more ST
Otter Tail Power Company Urges Environmental Protection Agency to Rescind Coal Combustion Residual Management Unit Regulations (10)
WASHINGTON, July 3 -- Otter Tail Power Co., Fergus Falls, Minnesota, has submitted a public comment letter to the U.S. Environmental Protection Agency regarding proposed amendments to the coal combustion residuals rules, particularly focusing on the regulation of coal combustion residual management units. The electric utility, which serves approximately 134,200 customers across Minnesota, North Dakota, and South Dakota and operates coal-fired power plants in North Dakota and South Dakota, outlines concerns and recommendations aimed at refining more ST
Outsourcing Facilities Association Requests Clarifications on Food and Drug Administration Draft Guidance for Responding to Form 483 Observations (10)
WASHINGTON, July 3 -- The Outsourcing Facilities Association has submitted a public comment letter to the U.S. Food and Drug Administration regarding the agency's draft guidance titled Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection. The OFA represents FDA-registered outsourcing facilities operating under Section 503B of the Federal Food, Drug, and Cosmetic Act, which provide compounded medications to patients and healthcare providers. The letter supports the FDA's efforts to improve transparency and foster e more ST
Paltown Development Foundation Calls for Reforms to Prior Authorization in Cancer Testing (10)
WASHINGTON, July 3 -- The Paltown Development Foundation, a nonprofit organization in Edgewater, Maryland, that advocates for colorectal cancer patients and their caregivers, submitted a public comment letter to the U.S. Department of Health and Human Services Centers for Medicare & Medicaid Services. The letter addresses challenges created by prior authorization requirements that delay medically necessary laboratory and biomarker testing critical for cancer treatment decisions.
The foundation emphasizes that in cancer care, timing is essentia more ST
Paradigm Health Advocates for AI-Driven Real-Time Clinical Trial Innovations (10)
WASHINGTON, July 3 -- Paradigm Health, Dallas, Texas, has submitted a public comment letter to the U.S. Food and Drug Administration responding to its Request for Information on the AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. The organization emphasized the need to modernize clinical trials through native electronic health record integration and advanced artificial intelligence that enables continuous patient safety and efficacy monitoring instead of traditional static data gathering.
Paradigm Health outlined a techno more ST
Partnership for Innovation and Empowerment Urges Strengthened Prior Authorization Rules to Improve Drug Access (10)
WASHINGTON, July 3 -- The Partnership for Innovation and Empowerment has submitted a public comment letter to the Centers for Medicare and Medicaid Services expressing support for the agency's 2026 proposed interoperability standards and prior authorization for drugs rule while recommending further enhancements.
PIE highlights the struggles faced by Black and low-income communities, emphasizing that delays in medication access often result from outdated prior authorization processes reliant on phone and fax communications.
PIE backs CMS's pro more ST
Partnership to Empower Physician-Led Care Urges Centers for Medicare & Medicaid Services to Enhance Patient Event Notifications for Value-Based Care (10)
WASHINGTON, July 3 -- The Partnership to Empower Physician-Led Care submitted a public comment letter to the Centers for Medicare & Medicaid Services addressing the Interoperability Standards and Prior Authorization for Drugs Proposed Rule. PEPC emphasized the role of small and independent physician practices in achieving value-based care and highlighted the challenges these providers face with current health information technology infrastructure.
PEPC urged CMS to strengthen health information exchanges (HIEs) by making them more open, capabl more ST
Patients Rising Calls for Patient-Centered Reforms to Prior Authorization Rules (10)
WASHINGTON, July 3 -- Patients Rising, a national patient advocacy organization, has submitted a public comment letter to the Centers for Medicare & Medicaid Services regarding the 2026 CMS Interoperability Standards and Prior Authorization for Drugs Proposed Rule. The organization supports the agency's initiative to modernize prior authorization procedures but stresses the need for specific enhancements to better protect patients facing chronic and serious illnesses.
The advocacy group highlights that prior authorization delays frequently res more ST
Patrice Kelly Consulting Critiques Limited Scope of Food and Drug Administration's Clinical Toxicology Exemption Proposal (10)
WASHINGTON, July 3 -- Patrice Kelly Consulting LLC, Arlington, Virginia, has submitted a public comment letter to the U.S. Department of Health and Human Services Food and Drug Administration concerning the agency's proposal to exempt certain class II clinical toxicology test system devices from premarket notification requirements. The company, representing clients involved in workplace drug and alcohol testing, argues the agency's current proposal falls short of what is required to streamline federal drug testing regulations.
The letter criti more ST
Patrice Kelly Consulting Urges FDA to Fully Exempt Federal Drug Testing Devices From Premarket Notification (10)
WASHINGTON, July 3 -- Patrice Kelly Consulting, Arlington, Virginia, has called on the U.S. Food and Drug Administration to completely remove the 510(k) premarket notification requirements for all Federal drug testing devices, including class II clinical toxicology test systems. The consulting firm submitted a public comment letter to the FDA expressing concerns that the current Federal Register Notice proposal only partially exempts certain device product codes, which does not provide the Substance Abuse and Mental Health Services Administrati more ST
Pfizer Urges CMS to Strengthen Electronic Prior Authorization and Transparency in Prescription Drug Access (10)
WASHINGTON, July 3 -- Pfizer Inc., New York, has submitted a public comment letter to the Centers for Medicare & Medicaid Services expressing support for the agency's proposed rule aimed at improving interoperability standards and prior authorization processes for prescription drugs. The letter, sent on June 15, 2026, seeks to expand electronic prior authorization requirements to drugs covered under both medical and pharmacy benefits across Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Children's Health more ST
Pharmaceutical Care Management Association Urges Flexibility and Provider Adoption in Centers for Medicare & Medicaid Services Prior Authorization Rule (10)
WASHINGTON, July 3 -- The Pharmaceutical Care Management Association, Alexandria, Virginia, has submitted a public comment letter to the Centers for Medicare & Medicaid Services expressing both support and recommendations regarding the agency's 2026 Interoperability Standards and Prior Authorization for Drugs Proposed Rule. The letter highlights critical aspects of the proposed rule aimed at modernizing electronic prior authorization processes and enhancing interoperability within healthcare systems.
PCMA, representing pharmacy benefit manager more ST
Pharmaceutical Research and Manufacturers of America Urges CMS to Enhance Prior Authorization Transparency and Access (10)
WASHINGTON, July 3 -- The Pharmaceutical Research and Manufacturers has expressed its perspectives on the Centers for Medicare & Medicaid Services' proposed rule titled "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 Agencies and CHIP Managed Care Entities, and Issuers of Qualified Health Plans on the Federally-Facilitated Exchang more ST
Pharmaceutical Research and Manufacturers Urges Food and Drug Administration To Apply Risk-Based Approach In AI-Enabled Early Phase Clinical Trials Pilot (10)
WASHINGTON, July 3 -- The Pharmaceutical Research and Manufacturers has submitted a public comment letter to the U.S. Food and Drug Administration regarding the agency's request for information on its AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. PhRMA expressed support for the FDA's goals to leverage advances in artificial intelligence and data science to improve the efficiency, safety monitoring, dose selection, and informed decision-making during early-phase clinical trials while maintaining rigorous scientific scruti more ST
Pharmacy Health Information Technology Collaborative Urges Expanded Electronic Prior Authorization Standards for Medicare and Medicaid Drugs (10)
WASHINGTON, July 3 -- The Pharmacy Health Information Technology Collaborative, Alexandria, Virginia, provided a public comment letter to the Centers for Medicare & Medicaid Services regarding advance interoperability standards and prior authorization requirements for drugs covered under Medicare Advantage, Medicaid, CHIP, and Qualified Health Plans on the federally-facilitated exchanges. PHIT represents major national pharmacy associations and stakeholders involved in pharmacy health IT, advocating for enhanced technology use to improve pharma more ST
Philips Highlights Challenges and Opportunities in Prior Authorization for Durable Medical Equipment Under Medicare and Medicaid (10)
WASHINGTON, July 3 -- Philips, a health technology company headquartered in Cambridge, Massachusetts, submitted a public comment letter to the Centers for Medicare & Medicaid Services addressing issues related to prior authorization requirements under the proposed rule CMS-0062-P. The rule pertains to Medicare and Medicaid programs, focusing on interoperability standards and prior authorization for drugs and durable medical equipment, prosthetics, orthotics, and supplies for Medicare Advantage Organizations, Medicaid Managed Care Plans, state a more ST
Picture Health Highlights Trustworthy AI as Key to Optimizing Early-Phase Clinical Trials (10)
WASHINGTON, July 3 -- Picture Health, Cambridge, Massachusetts, provided a public comment letter to the U.S. Food and Drug Administration addressing the agency's Request for Information on the AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. The company emphasized the importance of trustworthy, interpretable artificial intelligence in enhancing patient stratification and safety monitoring within early-phase oncology trials. Picture Health offered recommendations aimed at designing an impactful pilot program that leverages t more ST
PointClickCare Urges Centers for Medicare & Medicaid Services to Enhance Patient Event Notifications for Improved Care Transitions (10)
WASHINGTON, July 3 -- PointClickCare, a healthcare technology company headquartered in Mississauga, Ontario, has submitted a public comment letter to the Centers for Medicare & Medicaid Services addressing the improvement of patient event notifications. In its response to CMS's Request for Information on patient event notifications, PointClickCare emphasizes actionability, workflow integration, and scalable governance as critical factors to enhance the utility and effectiveness of notifications across care settings, particularly in post-acute a more ST
Power Performance Enterprises Urges Environmental Protection Agency to Roll Back Emissions Standards, Citing High Costs and Marginal Gains (10)
WASHINGTON, July 3 -- Power Performance Enterprises, Tulsa, Oklahoma, submitted a public comment letter to the U.S. Environmental Protection Agency urging the retention of the proposed Tier 4 emissions standards postponement and recommending a thorough reassessment of the Tier 3 and Tier 4 regulatory frameworks under Clean Air Act Section 202(a). The entity called for a rollback to Tier 2 emissions standards while proposing a technology-neutral safe harbor for in-use vehicles that can demonstrate Tier 2-equivalent emissions performance.
The or more ST
PPEI Urges Environmental Protection Agency to Delay Tier 4 Standards and Reevaluate Emission Regulations (10)
WASHINGTON, July 3 -- PPEI, Memphis, Tennessee, submitted a public comment letter to the U.S. Environmental Protection Agency advocating for a postponement of Tier 4 emissions standards implementation while urging the agency to reevaluate the necessity of both Tier 3 and Tier 4 regulations. The letter contends that the incremental environmental benefits of these later tiers do not justify their substantial economic costs, and it proposes restoring Tier 2 standards along with establishing a technology-neutral safe harbor for in-use vehicles demo more ST
Prader-Willi Syndrome Group Urges CMS to Address Prior Authorization Barriers (10)
WASHINGTON, July 3 -- The Prader-Willi Syndrome Association USA, in Brandon, Florida, has submitted a public comment letter to the U.S. Department of Health and Human Services Centers for Medicare & Medicaid Services addressing concerns about prior authorization requirements that impact access to essential laboratory testing for individuals with Prader-Willi syndrome. This rare genetic disorder affects numerous bodily systems, necessitating frequent and timely lab testing for effective treatment and monitoring.
The association highlights that more ST
Presentient Technologies Proposes AI-Driven Pilot to Enhance Early-Phase Clinical Trial Efficiency (10)
WASHINGTON, July 3 -- Presentient Technologies Ltd, a biostatistics technology firm in London, England, submitted a public comment letter to the U.S. Food and Drug Administration regarding the agency's AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. The company introduced its BRAKES system, a deterministic AI algorithm designed to identify failing clinical trials earlier than conventional interim analyses while preserving trial integrity by limiting human access to unblinded data.
Presentient emphasized that BRAKES offers more ST
Prime Therapeutics Urges Centers for Medicare & Medicaid Services to Extend Compliance Deadlines and Refine Drug Prior Authorization Standards (10)
WASHINGTON, July 3 -- Prime Therapeutics LLC, Eagan, Minnesota, has submitted a public comment letter to the Centers for Medicare & Medicaid Services outlining its support for modernization efforts within the agency's proposed rule on interoperability standards and prior authorization for drugs. While endorsing the policy direction aimed at advancing electronic prior authorization and interoperability, Prime Therapeutics has called for several operational refinements and extended timelines to ensure successful implementation and sustain the int more ST
Prior Authorization Practices Criticized by American Clinical Laboratory Association as Impeding Patient Care (10)
WASHINGTON, July 3 -- The American Clinical Laboratory Association has submitted a public comment letter to the Centers for Medicare & Medicaid Services regarding prior authorization practices affecting clinical laboratory testing. The letter offers insights about the challenges laboratories face with prior authorization processes, particularly those imposed by Medicare Advantage plans and other payers, and proposes recommendations for reform.
ACLA represents leading laboratories nationwide and advocates for policies expanding access to high-q more ST
Produce Industry Association Urges Food and Drug Administration to Clarify Traceability Guidance for Food Safety Modernization Act 204 Implementation (10)
WASHINGTON, July 3 -- The International Fresh Produce Association, Arlington, Virginia, has submitted a comprehensive public comment letter to the U.S. Food and Drug Administration regarding the draft guidance titled "Questions and Answers About Requirements for Additional Traceability Records for Certain Foods: Guidance for Industry." This draft guidance pertains to requirements under Section 204 of the Food Safety Modernization Act, focusing on traceability records for certain foods, including fresh produce.
IFPA emphasized its strong suppor more ST
Public Opposition and Property Concerns Raised Over Mid-States Corridor Project by Indiana Stakeholders (10)
WASHINGTON, July 3 -- The Mid-States Corridor project currently under review by the U.S. Department of Transportation has attracted substantial public comment from Indiana residents and business owners, including the Lochmueller Group of Evansville, Indiana. These stakeholders have submitted detailed feedback expressing apprehension about potential displacement of families and disruption of local farms and businesses within Southern Indiana.
Residents and agricultural landowners have voiced strong opposition to the project citing threats to ho more ST
QuantHealth Urges Food and Drug Administration to Embrace AI-Driven Simulation for Early-Phase Clinical Trial Optimization (10)
WASHINGTON, July 3 -- QuantHealth, a clinical-AI company headquartered in New York, has submitted a public comment letter to the U.S. Food and Drug Administration regarding the agency's pilot program aimed at AI-enabled optimization of early-phase clinical trials. The company emphasized patient-level simulation of clinical trials as a central capability that could transform decision quality, participant safety, system performance, and regulatory trustworthiness. QuantHealth's platform leverages extensive data from 350 million U.S. patients alon more ST
Quest Diagnostics Calls for Reform of Prior Authorization Policies Affecting Laboratory Testing (10)
WASHINGTON, July 3 -- Quest Diagnostics, a leading diagnostic information services provider headquartered in Secaucus, New Jersey, has submitted a public comment letter to the Centers for Medicare & Medicaid Services addressing challenges posed by current prior authorization requirements for laboratory tests under Medicare Advantage programs and other payers. The company's detailed response to the agency's Request for Information highlights administrative burdens, patient access impediments, and proposes a series of policy recommendations aimed more ST
Red Cedar Gathering Company Urges Environmental Protection Agency to Exclude Non-Emission Activities From New Source Review Construction Rules (10)
WASHINGTON, July 3 -- Red Cedar Gathering Co., Durango, Colorado, submitted a public comment letter to the U.S. Environmental Protection Agency regarding proposed amendments to the "Begin Actual Construction" provisions under the New Source Review preconstruction permitting program. The company advocates for clearer separation between emission-generating construction activities and non-emitting elements within the NSR's regulatory scope.
The company supports the agency's objective to distinguish stationary source construction from non-emitting more ST
Roderick and Solange MacArthur Justice Center Opposes Certification of Mississippi Capital Counsel System (10)
WASHINGTON, July 3 -- The Roderick and Solange MacArthur Justice Center, a national civil rights organization in New Orleans, Louisiana, has submitted a public comment letter opposing the Mississippi Attorney General's application to the U.S. Department of Justice for certification of the state's scheme for appointing post-conviction counsel in capital cases. The application requests approval under 28 U.S.C. Sec. 2265, which would allow Mississippi expedited habeas corpus proceedings in capital cases by certifying that it has an adequate mechan more ST
RTI International Partners with Savana on Food and Drug Administration Public Comment for AI-Enabled Clinical Trials (10)
WASHINGTON, July 3 -- RTI International, Durham, North Carolina, in collaboration with the technology platform provider Savana, based in Madrid, Spain, has submitted a comprehensive public comment letter to the U.S. Food and Drug Administration. The letter response addresses the agency's request for information regarding the design and implementation of an AI-enabled pilot program aimed at optimizing early-phase clinical trials.
Their joint proposal emphasizes the potential of artificial intelligence (AI) to transform clinical trials through n more ST
Sanofi Urges Centers for Medicare & Medicaid Services to Enhance Prior Authorization Process for Prescription Drugs With AI Oversight and Patient Protections (10)
WASHINGTON, July 3 -- Sanofi, a biopharmaceutical company in Cambridge, Massachusetts, submitted a public comment letter to the Centers for Medicare & Medicaid Services regarding the agency's proposed rule on interoperability standards and prior authorization for prescription drugs under Medicare Advantage, Medicaid managed care, and Federally Facilitated Exchanges. The company expressed strong support for CMS's efforts to modernize prior authorization processes to enhance patient access and reduce administrative burdens, while emphasizing the more ST
Santee Cooper Urges Environmental Protection Agency to Revise Coal Combustion Residual Closure Certification Criteria (10)
WASHINGTON, July 3 -- The South Carolina Public Service Authority, known as Santee Cooper and headquartered in Moncks Corner, South Carolina, presented its views to the U.S. Environmental Protection Agency regarding proposed Legacy and Coal Combustion Residual Management Unit Amendments. The public comment letter underscores concerns about the agency's plans to introduce a new certification pathway for closure by removal of legacy coal combustion residual impoundments closed prior to November 8, 2024, under the oversight of state or federal aut more ST
Schneider Analytics Urges BTS to Expand National Active Transportation Data Infrastructure (10)
WASHINGTON, July 3 -- Schneider Analytics, a public transportation planning and analysis firm in Washington state, offered comprehensive input to the U.S. Department of Transportation's Bureau of Transportation Statistics regarding the agency's Request for Information on shaping its future data and information products. The firm called for a strategic expansion of BTS's data collection and analytical focus to include nationally consistent, geospatially detailed measures of active transportation infrastructure, encompassing sidewalks, bicycle la more ST
ScienceEdgeRCI Proposes Quality Criteria for AI in Early-Phase Clinical Trials (10)
WASHINGTON, July 3 -- ScienceEdgeRCI LLC, Seattle, Washington state, has submitted a public comment letter to the U.S. Food and Drug Administration regarding the agency's pilot program on AI-enabled optimization of early-phase clinical trials. The company, known for its Parallax decision-intelligence platform, emphasized the importance of measurable quality in AI-assisted decision-making for trial go/no-go calls.
ScienceEdgeRCI outlined four key evaluation criteria for the pilot program: calibration, auditability and reproducibility, honest tr more ST
SCLC Global Policy Initiative Supports Centers for Medicare and Medicaid Services Proposal to Reform Prior Authorization Processes (10)
WASHINGTON, July 3 -- The SCLC Global Policy Initiative has submitted a public comment letter to the Centers for Medicare and Medicaid Services regarding the 2026 Interoperability Standards and Prior Authorization for Drugs Proposed Rule. The organization, which advocates for the civil, economic, and social rights of Black Americans and marginalized communities, expressed support for the proposed rule while urging stronger measures to address systemic healthcare inequities.
SCL-GPI emphasized that prior authorization procedures disproportionat more ST
SCLC Global Policy Initiative Urges Centers for Medicare and Medicaid Services to Reform Prior Authorization Process to Address Healthcare Inequities (10)
WASHINGTON, July 3 -- The SCLC Global Policy Initiative offered public comment to the Centers for Medicare and Medicaid Services supporting the agency's proposed 2026 Interoperability Standards and Prior Authorization for Drugs Rule.
The organization, dedicated to advancing civil and economic rights for Black Americans and marginalized communities, emphasized healthcare equity as central to its mission and critical in addressing longstanding barriers embedded in prior authorization practices.
SCLC Global Policy Initiative advocated for CMS to more ST
Sequoia Project Urges Centers for Medicare & Medicaid Services to Advance Interoperability and Prior Authorization Standards for Medicare and Medicaid Programs (10)
WASHINGTON, July 3 -- The Sequoia Project, a public-private collaborative in Reston, Virginia, submitted a public comment letter to the Centers for Medicare & Medicaid Services regarding the agency's proposed rule on interoperability standards and prior authorization for Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Children's Health Insurance Program Agencies, CHIP Managed Care Entities, and issuers of Qualified Health Plans on Federally-Facilitated Exchanges. The letter addresses CMS's efforts to enha more ST
Sheer Health Advocates for Expanded Interoperability Standards and Patient Access APIs (10)
WASHINGTON, July 3 -- Sheer Health, a healthcare technology company in New York, has submitted a public comment letter to the Centers for Medicare & Medicaid Services supporting CMS's proposed rule focused on enhancing interoperability standards. The company emphasized the importance of improved patient access APIs and made recommendations to expand the scope of payers required to expose these APIs.
Sheer Health stressed that providing access to prior authorization data for prescription drugs marks a substantial improvement in transparency and more ST
Sierra Club Michigan Chapter and Micah 6:8 Mission Oppose Environmental Protection Agency's Proposed New Source Review Construction Rule Changes (10)
WASHINGTON, July 3 -- The Sierra Club Michigan Chapter, Detroit, and the community organization Micah 6:8 Mission based in Southwest Louisiana have submitted a public comment letter to the U.S. Environmental Protection Agency expressing opposition to the agency's May 13, 2026, proposed rule titled "Begin Actual Construction in the New Source Review Preconstruction Permitting Program." The proposed rule aims to increase flexibility for industrial facilities by allowing them to begin certain construction activities prior to obtaining an NSR permi more ST
Sintavia Urges Mandatory Flowdown of Controlled Unclassified Information Requirements to Subcontractors (10)
WASHINGTON, July 3 -- Sintavia, Hollywood, Florida, has submitted a public comment letter to the General Services Administration regarding the Federal Acquisition Regulation proposed rule on Controlled Unclassified Information requirements, specifically addressing concerns about the optional nature of Standard Form XXX flowdown to subcontractors. Sintavia, a defense-focused advanced manufacturing company serving as a Tier 1 and Tier 2 supplier for U.S. Navy, Air Force, and other federal programs, highlights operational challenges arising from t more ST
Smart Health Network Urges Centers for Medicare & Medicaid Services to Advance FHIR-Based Prior Authorization and API Directory Standards (10)
WASHINGTON, July 3 -- Smart Health Network, Delaware, has submitted a public comment letter to the Centers for Medicare & Medicaid Services regarding the agency's proposed 2026 Interoperability Standards and Prior Authorization for Drugs rule. The letter urges CMS to adopt measures that strengthen prior authorization processes, extend electronic prior authorization to medical benefit drug claims, and establish a national API endpoint directory to improve healthcare data interoperability.
Smart Health Network, which operates a mission-driven in more ST
Smith Institute Urges Structural Reform of Prior Authorization in Federal Programs (10)
WASHINGTON, July 3 -- The Smith Institute, Tallahassee, Florida, submitted a public comment letter to the U.S. Department of Health and Human Services Centers for Medicare & Medicaid Services addressing the agency's proposed rule on Interoperability Standards and Prior Authorization for drugs under Medicare Advantage, Medicaid, CHIP, and Qualified Health Plans. The letter outlines concerns that the current prior authorization (PA) system has drifted from its original clinical purpose into a largely financial tool that has become a barrier to pa more ST
Society of General Internal Medicine Calls for Expanded Prior Authorization Reforms in Medicare and Medicaid Programs (10)
WASHINGTON, July 3 -- The Society of General Internal Medicine, Alexandria, Virginia, has submitted a public comment letter to the Centers for Medicare & Medicaid Services recommending enhanced reforms to prior authorization processes in Medicare Advantage, Medicaid, Children's Health Insurance Program, and qualified health plans on the federal exchanges. The organization, representing over 3,300 general internal medicine physicians, emphasizes the need to reduce administrative burdens and improve patient access to clinically appropriate therap more ST
South Carolina Manufacturers and Commerce Supports Environmental Protection Agency's Proposed NSR Construction Rule Revisions (10)
WASHINGTON, July 3 -- South Carolina Manufacturers and Commerce, Columbia, has expressed support for the U.S. Environmental Protection Agency's proposed revisions to the definition of "begin actual construction" within the New Source Review preconstruction permitting program. SCMC submitted its public comment letter to the EPA regarding the proposed rule published on May 13, 2026, which aims to clarify regulatory ambiguities and reduce project delays for manufacturers and other industries impacted by NSR permits.
The current NSR regulatory fra more ST
South Coast Air Quality Management District Challenges Environmental Protection Agency Proposal on New Source Review Construction Definitions (10)
WASHINGTON, July 3 -- The South Coast Air Quality Management District, Diamond Bar, California, has submitted a public comment letter to the U.S. Environmental Protection Agency expressing concerns over EPA's proposed rule titled "Begin Actual Construction" in the New Source Review Preconstruction Permitting Program. The letter criticizes the EPA's attempt to revise the New Source Review air permitting regulations, arguing that the changes would undermine longstanding regulatory clarity and weaken the preconstruction review requirements intende more ST
South Texas Lighthouse for the Blind Addresses Proposed Revisions to AbilityOne Program Rules (10)
WASHINGTON, July 3 -- The South Texas Lighthouse for the Blind, San Antonio, Texas, has submitted a public comment letter to the U.S. AbilityOne Commission regarding the Commission's proposed rulemaking on central nonprofit agencies' fee requirements and subcontracting policies within the AbilityOne Program.
The nonprofit agency, which provides employment opportunities for people who are blind through manufacturing, distribution, and retail operations supporting federal military and agency customers, expressed broad support for reforms aimed a more ST
Southeast Healthcare Urges Centers for Medicare & Medicaid Services to Strengthen Interoperability and Prior Authorization Rules to Support Medically Underserved Patients (10)
WASHINGTON, July 3 -- Southeast Healthcare, a comprehensive provider of mental health, chemical dependency, healthcare, and homeless services in Ohio, has submitted a public comment letter to the Centers for Medicare & Medicaid Services regarding the agency's 2026 proposed rule on Interoperability Standards and Prior Authorization for drugs across Medicare Advantage Organizations, Medicaid Managed Care Plans, Children's Health Insurance Program entities, and Qualified Health Plans on the Federally-Facilitated Exchange. The letter addresses Sout more ST
SS&C Health Calls for Delay in Centers for Medicare and Medicaid Services Prior Authorization API Implementation (10)
WASHINGTON, July 3 -- SS&C Health, New York, has urged the Centers for Medicare & Medicaid Services to postpone provisions concerning prior authorization data exchange mandated in the proposed rule related to Medicare Advantage, Medicaid, CHIP, and federal exchange health plans. The company, which provides healthcare and pharmacy claims software and services to health plans covering roughly 52 million lives, identified concerns over tight timelines and overlapping requirements with existing FHIR API mandates set for 2027.
The organization note more ST
Stedi Urges CMS to Retain X12 Standards While Integrating FHIR for Clinical Data Exchange in Prior Authorization (10)
WASHINGTON, July 3 -- Stedi Inc., a health care clearinghouse based in San Francisco, California, has submitted a public comment letter to the Centers for Medicare & Medicaid Services regarding the agency's proposed rule CMS-0062-P on interoperability standards and prior authorization for drugs. The letter addresses the balance between maintaining established X12 transaction standards and adopting Fast Healthcare Interoperability Resources standards for specific components of prior authorization workflows.
Stedi strongly supports CMS's efforts more ST
Sthenic Labs Proposes Hardware-Rooted Regulatory Framework for AI-Enabled Clinical Trials (10)
WASHINGTON, July 3 -- Sthenic Labs, Austin, Texas, submitted a public comment letter to the U.S. Food and Drug Administration addressing regulatory challenges in decentralized clinical trials involving AI. The letter outlines the "Sthenic Protocol," a pioneering hardware-rooted architecture designed to bridge the gap between physical trial materials and digital data systems to prevent synthetic fraud, ensure dose veracity, and enhance regulatory compliance.
The firm highlights a critical issue termed the "Veracity Gap," where existing data-ing more ST
Stryker Urges Food and Drug Administration to Exclude Powered Air-Purifying Respirators From Enforcement Policy and Maintain Rigorous Standards for Respirators in Healthcare (10)
WASHINGTON, July 3 -- Stryker Orthopaedic Instruments, Portage, Michigan, submitted a public comment letter to the U.S. Food and Drug Administration concerning the agency's draft guidance titled "Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators; Draft Guidance for Industry and Food and Drug Administration Staff." The submission addressed the FDA's proposed approach aimed at streamlining the regulatory review process to expedite access to respiratory protective devices critical to more ST
Survivors for Solutions Warns Centers for Medicare and Medicaid Services That Generic Treatment Denials Harm Neurological Patients (10)
WASHINGTON, July 3 -- Survivors for Solutions, a patient advocacy organization based in Washington, New Jersey, submitted a public comment letter to the Centers for Medicare and Medicaid Services addressing concerns about prior authorization and step therapy policies. The group highlighted barriers these protocols create in timely access to necessary treatments, particularly for patients with progressive neurological diseases such as multiple sclerosis and Alzheimer's disease.
The organization emphasized that prior authorization often delays c more ST
Susan G. Komen Supports Centers for Medicare and Medicaid Services Efforts to Streamline Prior Authorization for Breast Cancer Treatments (10)
WASHINGTON, July 3 -- Susan G. Komen, a leading breast cancer nonprofit in Dallas, Texas, has expressed support for the Centers for Medicare & Medicaid Services' proposed rule to standardize and improve prior authorization processes for prescription drugs under Medicare, Medicaid, and other health plans. The organization submitted a public comment letter to CMS outlining concerns and recommendations to enhance patient access to timely breast cancer care.
Komen praised CMS for expanding electronic PA requirements to cover drugs under both medic more ST
Takeda Pharmaceuticals Urges CMS to Improve Step Therapy Processes for Patient Care (10)
WASHINGTON, July 3 -- Takeda Pharmaceuticals submitted a public comment letter to the Centers for Medicare and Medicaid Services addressing the agency's proposed rule on interoperability standards and prior authorization for drugs used by Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Children's Health Insurance Program Agencies, and issuers of qualified health plans on federally-facilitated exchanges. Takeda, a global biopharmaceutical company focused on developing treatments in various therapeutic area more ST
Telyria Advocates for Protocol-Bound Signal Packets in Food and Drug Administration AI-Enabled Early-Phase Clinical Trials Pilot Program (10)
WASHINGTON, July 3 -- Telyria, Boston, Massachusetts, has submitted a public comment letter to the U.S. Food and Drug Administration regarding the agency's AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. The letter outlines a comprehensive pilot architecture and evaluation framework designed to enhance early signal visibility, participant safety, and decision quality in early-phase clinical trials, while ensuring data integrity, privacy, and human regulatory oversight remain central.
Telyria's response emphasizes structur more ST
Tennessee Hospital Association Urges Centers for Medicare & Medicaid Services to Enhance Drug Prior Authorization Interoperability Standards (10)
WASHINGTON, July 3 -- The Tennessee Hospital Association, Brentwood, submitted a public comment letter to the Centers for Medicare & Medicaid Services regarding proposed updates to interoperability standards and prior authorization requirements for drugs under Medicare Advantage, Medicaid Managed Care, CHIP, and Qualified Health Plans. The association represents over 160 healthcare facilities and emphasized support for modernizing prior authorization processes to reduce administrative burden and patient care delays.
The association highlighted more ST
Tennessee Raises Concerns on Environmental Protection Agency's Proposed New Source Review Construction Definitions and Permit Conditions (10)
WASHINGTON, July 3 -- The Tennessee Department of Environment and Conservation Division of Air Pollution Control, Nashville, submitted a public comment letter to the U.S. Environmental Protection Agency on June 29, addressing proposed revisions to the New Source Review preconstruction permitting program. The EPA's proposal aims to clarify distinctions between beginning actual construction of stationary sources and construction of non-emitting components or structures, as well as to allow certain non-emitting activities to occur prior to securin more ST
Tessara Urges Centers for Medicare & Medicaid Services to Implement Independent Verification of Payer API Conformance to Enhance Reliability (10)
WASHINGTON, July 3 -- Tessara Inc., San Francisco, California, has submitted a public comment letter to the Centers for Medicare & Medicaid Services regarding the 2026 CMS Interoperability Standards and Prior Authorization for Drugs Proposed Rule. The letter addresses concerns about the proposed federal requirement for payers to maintain API technology conformant with FHIR standards, stressing the critical need for independent, automated verification mechanisms to ensure endpoint reliability and conformance over time.
Tessara operates a contin more ST
Tessera Urges Tiered Fee Structure for AbilityOne Central Nonprofit Agencies (10)
WASHINGTON, July 3 -- Tessera, Seattle, Washington state, participating in the AbilityOne Program, submitted a public comment letter to the U.S. AbilityOne Commission proposing revisions to how Central Nonprofit Agencies charge fees. Tessera, which employs over 2,000 individuals with disabilities and veterans nationwide, recommended restructuring the CNA fee model to better reflect operational realities and incentivize program growth and contractor performance.
The letter highlighted that CNA efforts are heavily concentrated during initial con more ST
Texas Commission on Environmental Quality Endorses Environmental Protection Agency Proposed Revisions for New Source Review Construction Definitions (10)
WASHINGTON, July 3 -- The Texas Commission on Environmental Quality, Austin, has provided a public comment letter to the U.S. Environmental Protection Agency regarding the agency's proposed revisions to the New Source Review preconstruction permitting program. The agency's feedback supports the EPA's effort to update the definitions of "begin actual construction" and "pollutant-emitting activities" under both the Nonattainment New Source Review and Prevention of Significant Deterioration permitting programs, as well as related minor NSR regulat more ST
Texas Community Health Centers Urge CMS to Strengthen Prior Authorization and Interoperability Reforms (10)
WASHINGTON, July 3 -- The Texas Association of Community Health Centers, Austin, Texas, submitted a public comment letter to the Centers for Medicare & Medicaid Services addressing the agency's 2026 proposed rule on Interoperability Standards and Prior Authorization for drugs administered through Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Children's Health Insurance Program Agencies, CHIP Managed Care Entities, and issuers of Qualified Health Plans on the Federally-Facilitated Exchange. Representing more ST
Texas Health and Human Services Commission Raises Concerns Over CMS Proposed Rule on Prior Authorization and Interoperability Standards (10)
WASHINGTON, July 3 -- The Texas Health and Human Services Commission, Austin, Texas, has submitted a comprehensive public comment letter to the Centers for Medicare & Medicaid Services. The letter addresses the proposed rule known as 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 Agencies and CHIP Managed Care Entities, and Issuer more ST
Texas Health Services Authority Advocates for Extended Compliance and Expanded Standards in Centers for Medicare & Medicaid Services Interoperability Rule (10)
WASHINGTON, July 3 -- The Texas Health Services Authority, Austin, Texas, submitted a public comment letter to the U.S. Department of Health and Human Services Centers for Medicare & Medicaid Services addressing the proposed rule on Medicare and Medicaid Programs, Patient Protection and Affordable Care Act provisions, Interoperability Standards, and Prior Authorization for Drugs.
THSA urged CMS to implement a two-year moratorium on the compliance date of October 1, 2027, to allow non-payor organizations adequate time to validate real-world pri more ST
Thermo Fisher Scientific Proposes AI-Enabled Pilot Program to Optimize Early-Phase Clinical Trials (10)
WASHINGTON, July 3 -- Thermo Fisher Scientific, Wilmington, North Carolina, submitted a comprehensive public comment letter to the U.S. Food and Drug Administration addressing the forthcoming AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. The letter outlines detailed recommendations for the design, implementation, evaluation, and governance of the pilot, aiming to harness artificial intelligence to improve efficiency, decision quality, and participant safety in early-phase clinical trials.
The response underscores the po more ST
Transition Music Highlights Challenges for Small Music Libraries in Copyright Registration Fees (10)
WASHINGTON, July 3 -- Transition Music Corp., an independent production music library in Studio City, California, submitted a public comment letter to the U.S. Copyright Office concerning the agency's notice of inquiry on alternative fee structures for copyright registration. The company emphasized the unique challenges faced by small production music libraries when navigating registration options and fees.
Transition Music Corporation outlined that their catalog comprises hundreds of original instrumental works created by various independent more ST
Travis Association for the Blind Responds to AbilityOne Commission Proposed Rule on Program Fees and Subcontracting (10)
WASHINGTON, July 3 -- The Travis Association for the Blind, Austin, Texas, submitted a public comment letter to the U.S. AbilityOne Commission regarding the Commission's proposed rule revising central nonprofit agencies' requirements to charge fees and clarifying subcontracting within the AbilityOne Program. The program supports employment opportunities for people who are blind by providing products and services to Federal customers.
The Travis Association for the Blind expressed broad support for efforts to clarify rules on fees and subcontra more ST
Tribal Biotechnology And Health Consortium Urges Centers for Medicare & Medicaid Services To Address Tribal Implications In Proposed Interoperability Rule (10)
WASHINGTON, July 3 -- The Tribal Biotechnology & Health Consortium, represented by Clear Health Pass Holdings, Colorado Springs, Colorado, submitted a public comment letter to the Centers for Medicare & Medicaid Services concerning the 2026 CMS Interoperability Standards and Prior Authorization for Drugs Proposed Rule. The Consortium, which includes federally recognized Tribal Nations and tribally owned enterprises, emphasized the rule's significant tribal implications and the need for government-to-government consultation as mandated by Execut more ST
Tucson Electric Power Advocates for Site-Specific Risk Evaluation in Environmental Protection Agency Coal Combustion Residual Rule Amendments (10)
WASHINGTON, July 3 -- Tucson Electric Power Co., an electric utility in Arizona, has submitted formal comments to the U.S. Environmental Protection Agency regarding the agency's Proposed Rule on Legacy Coal Combustion Residual Management Units amendments. TEP, serving over 450,000 customers in southern Arizona and parts of Cochise County, operates coal-fired power plants including the Springerville Generating Station, which produce coal combustion residuals regulated under EPA standards.
In its public comment letter, TEP expressed support for more ST
UCB Advocates for AI Integration to Enhance Early-Phase Clinical Trials (10)
WASHINGTON, July 3 -- UCB Inc., a global biopharmaceutical company in Smyrna, Georgia, has provided comprehensive input to the U.S. Food and Drug Administration on the agency's AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. UCB emphasized that artificial intelligence can significantly improve the conduct of early clinical development, enhance patient outcomes, and optimize regulatory decision-making. The public comment letter highlights various facets of AI applications that the agency should consider to maximize the pilo more ST
Union Pacific Automated Track Inspection Waiver Faces Criticism Over Safety and Data Concerns (10)
WASHINGTON, July 3 -- The Brotherhood of Maintenance of Way Employees Division of the International Brotherhood of Teamsters submitted a public comment letter to the Federal Railroad Administration raising concerns about Union Pacific Railroad Company's second monthly reporting under the FRA's Automated Track Inspection waiver framework. The letter highlights ongoing issues with the reliability, coverage, and safety equivalence of ATI inspections compared to human visual inspections.
In the May 2026 reporting period, Union Pacific reported a r more ST
United Association Supports Environmental Protection Agency Proposal to Streamline Preconstruction Permitting Rules (10)
WASHINGTON, July 3 -- The United Association of Journeymen and Apprentices of the Plumbing and Pipe Fitting Industry of the United States and Canada, AFL-CIO, has expressed support for the U.S. Environmental Protection Agency's proposed rule to revise the definition of "begin actual construction" in the New Source Review preconstruction permitting program. The proposed changes aim to reduce regulatory delays impacting critical infrastructure projects under the Clean Air Act.
The United Association, representing over 400,000 skilled workers in more ST
UnitedHealth Group Urges Balanced Implementation of Centers for Medicare & Medicaid Services Drug Prior Authorization Standards and Cybersecurity Enhancements (10)
WASHINGTON, July 3 -- UnitedHealth Group, Minneapolis, Minnesota, has conveyed its positions and recommendations to the U.S. Department of Health and Human Services Centers for Medicare & Medicaid Services regarding the federal agency's proposed Interoperability Standards and Prior Authorization for Drugs Rule. The proposal aims to standardize electronic prior authorization processes across Medicare Advantage, Medicaid/CHIP, and Qualified Health Plans offered through Federally Facilitated Exchanges, thereby streamlining access and improving hea more ST
Unlearn.AI Urges Food and Drug Administration to Harness AI for Early-Phase Clinical Trial Innovation (10)
WASHINGTON, July 3 -- Unlearn.AI, a technology company in San Francisco, California, has submitted a public comment letter to the U.S. Food and Drug Administration regarding the agency's pilot program on AI-Enabled Optimization of Early-Phase Clinical Trials. The company emphasized the potential of artificial intelligence to enhance the efficiency, speed, and quality of decision-making in early-phase drug development trials, which it identifies as a critical bottleneck.
Unlearn.AI's response focuses on two primary AI-driven applications aimed more ST
Valer Urges Centers for Medicare & Medicaid Services to Resolve Data and Routing Complexities to Improve Prior Authorization Workflows (10)
WASHINGTON, July 3 -- Valer, Redwood City, California, has submitted a public comment letter to the U.S. Department of Health and Human Services Centers for Medicare & Medicaid Services and the Office of the National Coordinator for Health Information Technology regarding the proposed Interoperability Standards and Prior Authorization for Drugs rule. The letter highlights issues related to data fidelity and payer authorization routing complexities that Valer believes must be addressed to realize the promise of FHIR-enabled prior authorization w more ST
VeloxVFX Proposes Lifecycle-Separated Framework for Stablecoin Customer Identification Program Obligations (10)
WASHINGTON, July 3 -- VeloxVFX LLC, Bountiful, Utah, has submitted a public comment letter to the Financial Crimes Enforcement Network, the Office of the Comptroller of the Currency, the Board of Governors of the Federal Reserve System, the Federal Deposit Insurance Corporation, and the National Credit Union Administration. The letter addresses the joint proposed rule concerning the Permitted Payment Stablecoin Issuer Customer Identification Program, urging regulatory agencies to refine relationship classifications within the framework to boost more ST
Veolia Supports Environmental Protection Agency's Updated PFAS Disposal Guidance With Calls for Clear Standards (10)
WASHINGTON, July 3 -- Veolia, Boston, Massachusetts, submitted a public comment letter to the U.S. Environmental Protection Agency regarding the agency's Interim Guidance on the Destruction and Disposal of Perfluoroalkyl and Polyfluoroalkyl Substances and related materials. Veolia expressed support for EPA's commitment to accelerating action on PFAS pollution through proper destruction and disposal, noting the agency's shift to annual updates of the guidance to keep pace with evolving science and technology.
Veolia highlighted its unique capab more ST
ViiV Healthcare Urges Centers for Medicare & Medicaid Services to Strengthen Protections for HIV Treatment and Prevention Access (10)
WASHINGTON, July 3 -- ViiV Healthcare, Research Triangle Park, North Carolina, has submitted a public comment letter to the Centers for Medicare & Medicaid Services regarding the proposed rule on Medicare and Medicaid programs, interoperability standards, and prior authorization for drugs under the Patient Protection and Affordable Care Act. The letter strongly advocates for enhanced safeguards around the use of utilization management practices that affect antiretrovirals and pre-exposure prophylaxis for HIV treatment and prevention.
ViiV Heal more ST
Virginia Department of Transportation Seeks Clarifications on FAA Proposed UAS Flight Restrictions Near Infrastructure (10)
WASHINGTON, July 3 -- The Virginia Department of Transportation, Richmond, Virginia, submitted a public comment letter to the U.S. Department of Transportation regarding the Federal Aviation Administration's Notice of Proposed Rulemaking on restricting unmanned aircraft system operations near fixed site facilities. The department expressed support for the intent behind the proposed rule while seeking clarifications and collaboration to address potential conflicts with existing regulations and to preserve critical state authorities.
The letter more ST
Vivalink Advocates for Continuous Safety Monitoring in AI-Enabled Early-Phase Clinical Trials Pilot (10)
WASHINGTON, July 3 -- Vivalink Inc., Hayward, California, provided a comprehensive public comment letter to the U.S. Food and Drug Administration concerning the AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. The company, which develops medical-grade wearable biosensors and connected-health platforms for continuous physiological monitoring, emphasized the role of continuous safety monitoring within digital clinical trials. Vivalink shared its extensive operational experience supporting decentralized trials across more than more ST
VLS Environmental Solutions Urges Environmental Protection Agency to Clarify Class I Well Distinctions in PFAS Disposal Guidance (10)
WASHINGTON, July 3 -- VLS Environmental Solutions, Houston, Texas, has submitted a public comment letter to the U.S. Environmental Protection Agency regarding the agency's 2026 Interim Guidance on the Destruction and Disposal of PFAS. The company, a commercial provider specializing in Class I hazardous deep well injection disposal solutions, provided recommendations aimed at clarifying sections of the guidance to enhance understanding and consistent application of PFAS management technologies, particularly regarding underground injection wells. more ST
Vsoft Infoware Pitches Clinfoware eClinical Platform to Support Food and Drug Administration's AI Clinical Trial Pilot (10)
WASHINGTON, July 3 -- Vsoft Infoware Inc., New Jersey, submitted a public comment letter to the U.S. Food and Drug Administration outlining its Clinfoware eClinical platform as a ready solution to support the FDA's AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. The comments emphasize Clinfoware's patented comprehensive software architecture designed to enhance the efficiency and success rate of clinical trials, especially in adaptive early-phase settings.
The Clinfoware platform is based on an end-to-end transactional eC more ST
Waker Bioscience Calls for Enhancements in FDA Genome Editing Safety Assessment Guidance (10)
WASHINGTON, July 3 -- Waker Bioscience, Cambridge, Massachusetts, submitted a public comment letter to the U.S. Food and Drug Administration expressing support for the agency's April 2026 draft guidance titled "Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing." The company recommends the FDA finalize the draft guidance, noting its timely nature and comprehensive technical approach which extends the scope of the January 2024 guidance on human gene therapy products incorporating human genome edit more ST
Walsh Clinical Advisory Urges Food and Drug Administration to Prioritize Human Accountability in Clinical Trial AI Pilot (10)
WASHINGTON, July 3 -- Walsh Clinical Advisory, Annapolis, Maryland, submitted a public comment letter to the U.S. Food and Drug Administration regarding the agency's AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. The letter emphasizes that the primary limitation on artificial intelligence's value in early-phase clinical trials is not model accuracy but whether human decision ownership and workflow design are clearly established. According to the organization, simply deploying AI tools without redesigning oversight models more ST
West Texas Lighthouse for the Blind Addresses AbilityOne Commission Proposed Rule Changes (10)
WASHINGTON, July 3 -- The West Texas Lighthouse for the Blind, Midland, Texas, submitted a public comment letter to the U.S. AbilityOne Commission regarding the Commission's proposed rule revisions to Central Nonprofit Agencies' fee structures and subcontracting policies. The organization participates in the AbilityOne Program, which aims to provide employment opportunities for people who are blind by delivering products and services to federal customers.
The West Texas Lighthouse supports clarifications that the Program Fee is an allowable co more ST
Westchester Medical Center Health Network Urges CMS to Amend Medicaid Payment Rule to Protect Patient Care (10)
WASHINGTON, July 3 -- Westchester Medical Center Health Network, Valhalla, New York, has submitted a public comment letter to the Centers for Medicare & Medicaid Services responding to the proposed rule on Medicaid Managed Care State Directed Payments and Medicaid Fee-for-Service Targeted Medicaid Practitioner Payments. The health system expressed concerns that, if implemented without modification, the rule would jeopardize patient access to quality healthcare and conflict with legislative intent regarding the 180-day grandfathering period esta more ST
Western Growers Urges Food and Drug Administration to Enhance Traceability Guidance for Specialty Crop Supply Chain (10)
WASHINGTON, July 3 -- Western Growers, Irvine, California, submitted a public comment letter to the U.S. Food and Drug Administration addressing the agency's draft guidance titled "Questions and Answers About Requirements for Additional Traceability Records for Certain Foods: Draft Guidance for Industry." The letter offered detailed feedback and recommendations aimed at improving the clarity, consistency, and practicality of traceability standards for fresh fruits, nuts, and vegetables grown and handled primarily in California, Arizona, Colorad more ST
Westside Family Healthcare Urges Centers for Medicare & Medicaid Services to Enhance Prior Authorization and Interoperability Standards for Medically Underserved Patients (10)
WASHINGTON, July 3 -- Westside Family Healthcare, a Federally Qualified Health Center in Delaware, has submitted a public comment letter to the Centers for Medicare & Medicaid Services addressing the agency's proposed 2026 Interoperability Standards and Prior Authorization for Drugs rule. The organization provides vital family medical, prenatal, behavioral, oral, and women's health services to approximately 25,000 individuals in its community, many of whom are medically underserved and reliant on Medicaid and Medicare Advantage programs.
The l more ST
Wholechain Calls for FDA Clarification on Traceability Lot Code Practices and Shipping Procedures (10)
WASHINGTON, July 3 -- Wholechain, a traceability solutions provider in Bloomfield Hills, Michigan, submitted a public comment letter to the U.S. Food and Drug Administration concerning the Draft Guidance for Industry on Requirements for Additional Traceability Records for Certain Foods. The company urged the FDA to explicitly confirm that manufacturers may assign a single traceability lot code per product per shipment at the time of packing as an acceptable transformation event. This clarification aims to address challenges faced by industry in more ST
Witness to Innocence and Death Penalty Policy Project Oppose Florida's Habeas Corpus Certification Request (10)
WASHINGTON, July 3 -- Witness to Innocence, Philadelphia, Pennsylvania, together with the Death Penalty Policy Project, submitted a public comment letter to the U.S. Department of Justice opposing the State of Florida's application for certification under 28 U.S.C. Sec. 2265, known as Chapter 154 certification, which would accelerate and limit federal habeas corpus review in capital cases. These organizations argue that such certification would further restrict essential post-conviction appeals and jeopardize the rights of death row prisoners, more ST
Workgroup for Electronic Data Interchange Provides Comprehensive Input on Centers for Medicare & Medicaid Services Proposed Rule to Enhance Electronic Prior Authorization and Interoperability Standards (10)
WASHINGTON, July 3 -- The Workgroup for Electronic Data Interchange has submitted an extensive public comment letter to the Centers for Medicare & Medicaid Services regarding the agency's proposed rule titled "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 Agencies and CHIP Managed Care Entities, and Issuers of Qualified Health Pl more ST
Wyoming Department of Environmental Quality Offers Recommendations on Environmental Protection Agency's Interim PFAS Destruction and Disposal Guidance (10)
WASHINGTON, July 3 -- The Wyoming Department of Environmental Quality, Cheyenne, submitted a public comment letter to the Environmental Protection Agency regarding the agency's 2026 Interim Guidance on the Destruction and Disposal of Perfluoroalkyl and Polyfluoroalkyl Substances and materials containing PFAS. The letter addresses the need for clearer, more thorough guidance on managing, destroying, and disposing of PFAS contaminated materials, as well as the evolving regulatory landscape surrounding PFAS.
WDEQ underlines the critical importanc more ST
Wyoming Department of Environmental Quality Provides Input on Environmental Protection Agency New Source Review Rule (10)
WASHINGTON, July 3 -- The Wyoming Department of Environmental Quality, Cheyenne, submitted a public comment letter to the U.S. Environmental Protection Agency regarding the agency's proposed revisions to the New Source Review preconstruction permitting program. The WDEQ expressed support for the EPA's efforts to streamline air permitting while offering several recommendations to enhance clarity, preserve consistency with state regulations, and protect established authorities.
WDEQ urged the EPA to require submission of a complete air quality p more ST
Xellia Pharmaceuticals Calls for Adjusted Impurity Thresholds for Antibiotics in Food and Drug Administration Guidelines (10)
WASHINGTON, July 3 -- Xellia Pharmaceuticals ApS, Copenhagen, Denmark, has submitted a public comment letter to the U.S. Food and Drug Administration addressing impurity specifications for antibiotics. The company highlights a gap in current FDA guidelines regarding antibiotics produced by fermentation and semi-synthesis, as existing ICH Q3A and Q3B guidelines exclude these product types.
Xellia explains that antibiotics derived from fermentation often present complex and variable impurity profiles, making standard impurity thresholds inadequa more ST
Zenolabs AI Supports Rohan Sharma's Nomination to National Airspace System Advisory Committee (10)
WASHINGTON, July 3 -- Zenolabs AI LLC, Temecula, California submitted a public comment letter to the Federal Aviation Administration endorsing the nomination of Rohan Sharma for a seat on the National Airspace System Advisory Committee. The company highlighted Sharma's combined expertise in engineering, AI governance, and export compliance as vital for advancing the committee's mandate on integrating autonomous and unmanned aerial systems into the National Airspace System.
Zenolabs AI emphasized Sharma's role as a U.S. Delegate to the ISO/IEC more ST
Zhuhai GeneRulor Medical Technology Proposes Enhancements to Food and Drug Administration Guidance on Genome Editing Safety Assessment (10)
WASHINGTON, July 3 -- Zhuhai GeneRulor Medical Technology Co. Ltd., Zhuhai, Guangdong Province, China, has submitted a comprehensive public comment letter to the U.S. Food and Drug Administration regarding the agency's draft guidance titled "Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing," released in April 2026. The organization, a contract research service provider specializing in nonclinical safety evaluations for human genome editing therapeutic programs, offered multiple technical recomm more ST
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