"Because if we regulate medicine or medical device development too greatly, we will destroy the impetus for incremental discovery and breakthrough…"
"Let the FDA do their job collecting the safety information they need, and then let CMS be real and truthful about what kind of data they want, which is about cost and volume…"
The Gray Sheet, 2006 Aug 14. [subscription required]
"Though CMS claims it needs more safety data, the agency's indecision comes down to the issue of the product's high cost…"
The Gray Sheet, 2006 Apr 10. [subscription required]
"70% of medical technology companies do not have the resources to commercialize a technology…"
The Gray Sheet, 2005 May 23. [subscription required]
"However, we also recognize that we have international problems and issues. There is therefore an international side to our legislative agenda…"
"You can't function alone; you have to consider [reimbursement] as part of your planning process…"
The Gray Sheet, 2004 Feb 23. [subscription required]
"Anything that's coming into the marketplace now has a whole other hurdle to achieve…"
The Gray Sheet, 2003 Dec 29. [subscription required]
"Let's look at some of the really profoundly marginal interventions that are currently being practiced that Medicare fully funds…"
The Gray Sheet, 2003 Dec 29. [subscription required]
"How do they triage a NCD [National Coverage Decision]?…"
The Gray Sheet, 2002 Oct 7. [subscription required]
McClellan's Farewell Gifts Include Direction For Technology Council
The Gray Sheet, 2006 Oct 23
McClellan Resigns As CMS Chief, Saying Agency Has “Momentum.”
The Gray Sheet, 2006 Sep 11
Panel: Two Years Are Adequate for New-Technology APCs.
Medical Device Daily, 2006 Aug 28
Bye bye Boston Sci; hello NeoCure – Richner.
The Gray Sheet, 2006 Jul 24
Cost-Benefit Decisions Will Reside With Docs/Patients, Not CMS – McClellan.
The Gray Sheet, 2005 May 23
Patient-Reported Outcomes In Device Trials: FDA Guidance Under Review.
The Gray Sheet, 2004 May 24
DES Rates Sustained, CMS Exerting Price Pressures: Payment Recap.
The Gray Sheet, 2003 Dec 29
Scully’s Successor Awaited By Device Reps: Will Improved Access Continue?
The Gray Sheet, 2003 Dec 8
Shaping the Future.
MX, 2003 Jul/Aug
CMS May Use Med-Tech Council To Address Small Company Concerns.
The Gray Sheet, 2003 June 16
Draft Guidance On NCD MCAC Referral Has Ongoing Comment Period.
The Gray Sheet, 2003 May 12
Tunis Presses NIH To Share ICD Study Findings; Dollens Claims Data Irrelevant.
The Gray Sheet, 2003 Mar 31
Chart: Medicare Technology Coverage Policy Developments 2002-2003.
The Gray Sheet, 2003 Jan 6
Japanese Reimbursement Reforms: Manufacturers Torn, Physicians Defiant.
The Gray Sheet, 2002 Nov 4
Medical Alley’s Meskan Is Boston Scientific/Scimed Reimbursement Director.
The Gray Sheet, 2002 Jul 15
Coverage Time Lag Can Be Solved By Gathering Data Early On, Gustafson Says.
The Gray Sheet, 2002 Apr 22
SIRIUS Cost Data Suggests Higher Inpatient Payment Level For Eluting Stents.
The Gray Sheet, 2002 Mar 25
HCFA No More.
MX, 2001 Sep/Oct
Industry Roundtable: In Search of an Earlier Payday.
MX, 2001 Jan/Feb
Boston Scientific Looks For Experienced Reimbursement Advocate In D.C.
The Gray Sheet, 2001 Sep 24
MCAC Amendments Open Up Panel Process, Broaden Scope of Reviews.
The Gray Sheet, 2001 Mar 5
PET Imaging Fate Uncertain Following Limited Medicare Coverage Review.
The Gray Sheet, 2000 Nov 13
Medical Alley.
The Gray Sheet, 2000 Jun 26
Instructions To MCAC Panels Will Not Lead To Coverage Delays, HCFA Says.
The Gray Sheet, 2000 Mar 6
HCFA Letter to HIMA Supports Strong Role For MCAC Executive Committee.
The Gray Sheet, 2000 Jan 24