Regulatory Comments/Rulings
National Patient Advocate Foundation actively supports regulatory proposals that improve access to healthcare. As part of its Federal Government Affairs Program, NPAF submits comments to Regulatory Agencies, including the Food and Drug Administration (FDA) and the Department of Health and Human Services (DHHS), in an effort to incorporate the patient voice in regulatory decisions.
NPAF Comments re: Drug Shortages Task Force and Strategic Plan; Request for Comments - March 2013
NPAF Comments re: Streamline Applications - February 2013
NPAF Comments re: Medicaid, Children’s Health Insurance Programs, and Exchanges - February 2013
REAP Comments Medicaid, Children’s Health Insurance Programs, and Exchanges. - February 2013
NPAF Comments on Framework for Pharmacy Compounding State and Federal Roles. - January 2013
NPAF Comment Letter on Part C&D Star Ratings. - January 2013
PCORI Draft Methodology Report - September 2012
NPAF Comments Re: Using Patient-Reported Outcomes in Registries Draft White Paper - July 2012
NPAF Comments Re: May 2, 2012 Open Letter on Medicare and Medicaid Waste, Fraud, and Abuse - June 2012
NPAF Comments Re: Nationwide Health Information Network: Conditions for Trusted Exchange - June 2012
NPAF Comments Re: May 16, 2012 General Guidance on Federally-facilitated Exchanges - June 2012
NPAF Comments Re: Oregon’s Selection of the State’s Essential Health Benefits Benchmark Plan - June 2012
NPAF Comments re: Draft Guidance Relating to the Development of Biosimilar Products - May 2012
NPAF Comment re: Medicare and Medicaid Programs; Electronic Health Record Incentive Program— Stage 2 - May 2012
Using Innovative Technologies and Other Conditions of Safe Use To Expand Which Drug Products Can Be Considered Nonprescription - May 2012
Interim Final Rule On The Establishment Of Exchanges And Qualified Health Plans MS-9989-F - May 2012
Performance Measurement Coordination Strategy For PPS-Exempt Cancer Hospitals - April 2012
NPFA FDA Public Hearing on Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practice - April 2012
Performance Measurement Coordination Strategy for Hospice and Palliative Care - April 2012
REAP FDA Public Hearing on Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practice - April 2012
NPAF Comments Re: Evaluation of Sex Differences in Medical Device Clinical Studies - March 2012
PCORI Comments on Draft National Priorities for Research and Research Agenda - March 2012
CMS Proposed Decision Memo for Transcatheter Aortic Valve Replacement (TAVR) - March 2012
REAP Essential Health Benefits Bulletin Comment Letter - January 2012
Request for Adjustment to the Medical Loss Ratio (MLR) for the State of Wisconsin - January 2012
Request for Adjustment to the Medical Loss Ratio (MLR) for the State of North Carolina - January 2012
Extension of Essential Health Benefits Bulletin Comment Deadline - January 2012
Request for Adjustment to the Medical Loss Ratio (MLR) for the State of Kansas – December 2011
Request for Adjustment to the Medical Loss Ratio (MLR) for the State of Texas – December 2011
Request for Adjustment to the Medical Loss Ratio (MLR) for the State of Oklahoma – December 2011
Proposed Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2013 – December 2011
NPAF Comments: Medicaid Program: Eligibility Changes under the Affordable Care Act of 2010 - October 2011
NPAF Comments: Exchange Functions in the Individual Market: Eligibility Determinations; Exchange Standards for Employees - October 2011
NPAF Comments: Health Insurance Premium Tax Credit - October 2011
NPAF Comments: Establishment of Exchanges and Qualified Health Plans CMS-9989-P - October 2011
REAP Comment Letter re: Establishment of Exchanges and Qualified Health Plans Proposed Rules - October 2011
NPAF Comments Provided to HHS at Open Session on Consumer Advocates on Essential Health Benefits - October 2011
Summary of Benefits and Coverage and the Uniform Glossary - October 2011
Hospital Outpatient Prospective Payment System Proposed Rule for CY 2012 - August 2011
FDA Accelerated Approval Process - July 2011
Methods for Assuring Access to Covered Medicaid Services - July 2011
Opportunities for Alignment Under Medicaid and Medicare - July 2011
Methods for Assuring Access to Covered Medicaid Services - July 2011
Proposed Changes to the Hospital Inpatient Prospective Payment System for FY 2012 - June 2011
FDA_User_Fee_Program_for_Biosimilars - June 2011
Accountable Care Organizations - Waiver Designs - May 2011
Accountable Care Organizations - IRS Code - May 2011
Accountable Care Organizations - Antitrust Enforcement Policy - May 2011
Accountable Care Ogranizations - May 2011
Patient Notification of Right to Access State Survey - March 2011
Patient Notification of Medicare Medicaid LTC Closure - March 2011
Medicaid Community First Choice Option Program - March 2011
Revisions to Chapter 5 of the Medicare Managed Care Plan - March 2011
Value Based Insurance Design - February 2011
Rate Increase Disclosure and Review - February 2011
Revisions to the 2011 Medicare Marketing Guidelines - January 2011
Medical Loss Ratio Requirements under the ACA - January 2011
ODAC Regarding updates on new drug applications and biolgoics license applications - January 2011
Medicare Advantage and the Medicare Prescription Drug Benefit Program - January 2011
Requirements for Long Term Care Facilities; Hospice Services - December 2010
Parallel Review of Medical Products - December 2010
Request for Information Regarding ACOs and the Medicare Shared Savings Program - December 2010
Risk Evaluation and Mitigation Strategy (REMS) - August 2010
Revisions to Payment Policies Under the Physician Fee Schedule - August 2010
Hospital Outpatient Prospective Patient System - August 2010
Disclosure Policies of the U.S. Food and Drug Administration - July 2010
Erythropoietin Stimulating Agents (ESAs) for the Treatment of Chronic Kidney Disease (CKD) and Dialysis-related Anemia - July 2010
Prescription Drug User Fee Act Reauthorization - May 2010
Erythropoiesis-Stimulating Agents (ESAs) in Anemia Related to Kidney Disease - February 2010
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