Association for Diagnostics & Laboratory Medicine // Advocacy & Outreach // Comment Letters // 2011 Comment Letters

2011 Comment Letters

In July 2023, we changed our name from AACC (short for the American Association for Clinical Chemistry) to the Association for Diagnostics & Laboratory Medicine (ADLM). The following page links to resources that were written prior to the rebranding and/or mentions events that took place prior to the rebranding and that contain mentions of the association’s old name.

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

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

2011 Comment Letters

Legislative Issues

AACC supports congressional efforts to streamline the FDA de novo process

AACC opposes additional congressional cuts in laboratory payments

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

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

AACC opposes establishment of Medicare co-payment for laboratory services

AACC supports additional research funding for AHRQ

AACC supports continued funding for NIH National Children's Study

AACC opposes elimination of new Patient-Centered Outcomes Research Institute

AACC urges repeal of new Independent Payment Advisory Board

AACC backs effort to repeal new health care reform paperwork requirement

Regulatory Issues

AACC expresses concerns with CMS about use of troponin quality indicator

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

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

AACC supports improvements to the 510(K) process

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

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

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

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

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

AACC identifies HHS policies that merit regulatory review

AACC identifies FDA regulations that merit regulatory review

AACC supports greater oversight of DTC genetic tests

AACC supports expanded Medicare coverage for STI screening tests