Archived documents

Documents past their public comment period for Healthcare & Public Health.

EBSANPRM

Excepted Fertility Benefits

4,653 comments · 43 awaiting analysis

Net support +42% across analyzed comments

Top issues in comments

  • Expansion of fertility benefits
  • Restorative reproductive medicine
  • Moral status of embryos
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FDANotice

Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List

1,850 comments

Net support +90% across analyzed comments

Top issues in comments

  • Compounding safety and access
  • Patient access and affordability
  • Add specific peptides to 503a list
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CMSNPRM

Medicaid Program: Medicaid Managed Care State Directed Payments and Medicaid Fee-for-Service Targeted Medicaid Practitioner Payments

960 comments · 101 awaiting analysis

Net support -71% across analyzed comments

Top issues in comments

  • Medicaid reimbursement rates
  • Administrative burden and readiness
  • Elimination of state plan directed payments
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CMSProposed Rule

Medicare Program: Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2027 Rates; Requirements for Quality Programs; and Other Policy Changes

926 comments

Net support +12% across analyzed comments

Top issues in comments

  • Breakthrough device alternative pathways
  • Repeal of ntap alternative pathway
  • Methodology and risk adjustment
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CMSProposed Rule

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, etc.

721 comments

Net support +93% across analyzed comments

Top issues in comments

  • Timely access to care
  • Prior authorization requirements
  • Prior authorization delays
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FDARFI

Drug Repurposing for Unmet Medical Needs; Request for Information

608 comments

Net support +95% across analyzed comments

Top issues in comments

  • Drug repurposing for long covid
  • Expand fda-approved indications
  • Treatment for long covid
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FDARFI

AI-Enabled Optimization of Early- Phase Clinical Trials Pilot Program; Request for Information

239 comments · 2 awaiting analysis

Net support +94% across analyzed comments

Top issues in comments

  • Ai-enabled clinical trial optimization
  • Standardized evaluation framework
  • Ai bias and healthcare equity
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FDANotice

Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments - Biologics License Application (BLA) 125842 From Capricor, Inc. for Deramiocel (Human Allogeneic Cardiosphere-Derived Cells)

199 comments · 199 awaiting analysis

Analysis in progress

Top issues in comments

Not yet determined
Read the record →Closes Jul 29
CMSRFI

Request for Information: Comprehensive Review of the Essential Health Benefits Framework and Typical Employer Plan Standard

179 comments

Net support +77% across analyzed comments

Top issues in comments

  • Ehb definition and affordability
  • Premium costs
  • Out-of-pocket costs
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FDAOther

Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause; Draft Guidance for Industry

154 comments

Net support +94% across analyzed comments

Top issues in comments

  • Plausible mechanism framework
  • Regulatory framework for rare diseases
  • Post-approval data collection
Read the record →Closes Apr 28
FDAOther

General Considerations for the Use of New Approach Methodologies in Drug Development; Guidance for Industry - Draft Guidance

125 comments

Net support +82% across analyzed comments

Top issues in comments

  • Animal testing alternatives
  • Nam weight-of-evidence frameworks
  • Nam validation requirements
Read the record →Closes May 19
FDAOther

Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications—Considerations Related to Youth Risk - Draft Guidance for Industry

125 comments

Net support -26% across analyzed comments

Top issues in comments

  • Flavored vaping products
  • Harm reduction
  • Relative harm of products
Read the record →Closes May 12