Archives: Comments and Letters

• Comment Letters
• Position Papers & Policy Statements

Comment Letters

• 18 Jul 2001
  Comments on Proposed Health Canada Reclassification of Ultrasound Equipment 
  (13k)

• 28 Jun 2001
  Comment Letter to Food and Drug Administration's Dockets Management Branch 
  (13k)

• 18 Jun 2001
  Letter to Thomas Scully in Opposition to Requirement of Direct Physician Supervision of Specific Obstetric Ultrasound Procedures (6k)

• 06 Jun 2001
  Letter to David Feigal, MD on Third Party Quality System Audits (5k)

• 10 Apr 2001
  Letter to Dr. Sean Tunis in Opposition to HCFA Proposal to Establish Performance Standard for PET Devices for Purposes of Medicare Reimbursement (10k)

• 31 Jan 2001
  Comment Letter to Dr. Sean Tunis of HCFA Regarding Impact of Decision to Deny Coverage for PET Procedures Performed on Coincidence Imaging Devices Upon Member Companies (10k)

• 16 Jan 2001
  Comment Letter to HCFA on Medicare Coverage of FDG PET Procedures Performed on PET Systems (10k)

2000

• 31 Aug 2000
  FDA Docket No. 98N-0331 (CDRH Draft Guidance for Staff, Industry, and Third Parties Implementation of Third Party Programs Under the FDA Modernization Act of 1997) (26k)

• 24 Aug 2000
  Letter to Dr. John Whyte of HCFA Seeking Clarification on Statement in HCFA Decision Memorandum Pertaining to Actual Operational Acoustic Intensities of Diagnostic Ultrasound Devices (6k)

• 04 Aug 2000
  Letter to Secretary of Health and Human Services Donna Shalala on Expansion of PET Coverage  (5k)

• 19 Aug 2000
  Comments on Medicare Coverage Advisory Committee, Executive Committee, Interim Recommendations for Evaluating Effectiveness (10k)  

• 16 May 2000
  Comments on Health Care Financing Administration Notice of Intent to Publish a Proposed Rule (24k)

• 31 Mar 2000
  Process to Identify and Obtain Codes for Items Potentially Eligible for Payment as New Technologies or Transitional Pass-Throughs Under the Outpatient Prospective Payment System (10k)

• 17 Feb 2000
  Proposed Rule: Standards for Privacy of Individually Identifiable Health Information (25k)

1999

• 20 May 1999
  HCFA: Procedures for Making National Coverage Decisions for the Medicare Program

• 21 Jan 1999
  Comments on the Proceedings of the PET Town Hall Meeting, January 21, 1999

1998

• 08 Sep 1998
  Medicare Program: Prospective Payment System for Hospital Outpatient Services; 63 Federal Register 47551, September 8, 1998

Position Papers & Policy Statements

• 02 Aug 2001
  CMS Coverage Exclusion Decision for PET Coincidence Gamma Cameras  (20k)

• 19 Jun 2001
  Testimony Presented at Medicare Coverage Advisory Committee, Diagnostic Imaging Panel Meeting of June 19, 2001, in Support of Medicare Coverage for PET for Breast Cancer Applications (33k)  

• 14 Feb 2001
  Security and Privacy: An Introduction to HIPAA (68k)

• DHHS Healthcare Privacy Regulation and the Device Industry (53k) 

• Telemedicine: Public and Private Sector Issues Facing the Field (101k) 

• Recommendations for Implementing SPECT Quality Control from the Nuclear Medicine Section ()