2011 Comment Letters

ADLM continually tracks legislative and regulatory issues of importance to clinical laboratories and the clinical laboratory profession. This is a listing of ADLM's 2011 comment letters. ADLM commented on a wide range of topics to federal and state authorities.

Legislative Issues

AACC supports congressional efforts to streamline the FDA de novo process 

NOV.08.2011

AACC opposes additional congressional cuts in laboratory payments 

SEP.27.2011

AACC joins the Clinical Laboratory Coalition in opposing additional cuts in laboratory reimbursement 

SEP.07.2011

AACC joins Clinical Laboratory Coalition in opposing establishment of a Medicare laboratory co-payment 

JUL.11.2011

AACC opposes establishment of Medicare co-payment for laboratory services

JUN.01.2011

AACC supports additional research funding for AHRQ

APR.21.2011

AACC supports continued funding for NIH National Children's Study

MAR.02.2011

AACC opposes elimination of new Patient-Centered Outcomes Research Institute

FEB.23.2011

AACC urges repeal of new Independent Payment Advisory Board

FEB.23.2011 

AACC backs effort to repeal new health care reform paperwork requirement

FEB.07.2011  

Regulatory Issues

AACC expresses concerns with CMS about use of troponin quality indicator 

DEC.20.2011

AACC supports CMS efforts to protect patient privacy, but expresses concerns about laboratory access to de-identified excess specimens 

OCT.26.2011  

AACC supports CMS's efforts to allow patients greater access to their laboratory test results 

OCT.04.2011

AACC supports improvements to the 510(K) process 

SEP.06.2011

AACC expresses concerns with the impact of the FDA's RUO.IUO policy on the ability of labs to purchase critical devices needed to provide patient care 

AUG.23.2011

AACC supports the FDA's decision to downclassify devices for which safety and effectiveness is well established 

AUG.22.2011

AACC urges FDA to permit responsible laboratories continued access to RUO.IUO reagents 

AUG.03.2011

AACC supports CMS's decision to permit laboratories to bill Medicare without a physician signature 

JUL.18.2011

AACC urges CMS to maintain a mechanism for non MDs to bill for molecular diagnostic interpretations and reports 

JUL.18.2011

AACC identifies HHS policies that merit regulatory review 

JUN.27.2011

AACC identifies FDA regulations that merit regulatory review 

JUN.06.2011

AACC supports greater oversight of DTC genetic tests 

MAR.28.2011

AACC supports expanded Medicare coverage for STI screening tests 

MAR.22.2011