American Association for Clinical Chemistry
Better health through laboratory medicine
July 2007 Clinical Laboratory News: Washington Profiles

July 2007: Volume 33, Number 7

Proposed Funding for AHRQ to Study Comparative Effectiveness

Rep. Tom Allen (D-Maine) introduced the Enhanced Health Care Value for All Act (H.R.2184), which would provide additional funding for the Agency for Healthcare Research and Quality (AHRQ) to study the comparative effectiveness (CE) of healthcare products and services, like medical devices and medical procedures. The legislation provides AHRQ with $3 billion in public/private funds over the next 5 years to support and prioritize CE research. AACC is currently reviewing H.R.2184.

Over the past few years, many policymakers have argued in favor of using CE to improve patient care. The Medicare Payment Advisory Committee, among others, has suggested that CE studies compare the cost of technologies and use the data to assist in making coverage and payment decisions. A proposal by the Blue Cross Blue Shield Association (BCBS, Chicago, Ill.) would create an independent institute funded by health payers to pay for clinical trials, cohort studies, literature reviews, and other studies that evaluate the comparative clinical and cost effectiveness of different procedures, drugs, devices, and biologics. Sen. Hillary Clinton (D-N.Y.) supports this proposal, and has stated that she will soon be introducing legislation calling for CE research. But drug and device manufacturers are critical of these CE proposals, arguing that using cost data for such purposes may unnecessarily limit physician and patient treatment options and stifle innovation.

The BCBS proposal can be found online at Additional information on H.R.2184 can be found on the congressional Web site, THOMAS.

Senators Re-Introduce Health IT Bill

Senators Debbie Stabenow (D-Mich.) and Olympia Snowe (R-Maine) have re-introduced the Health Information Technology Act of 2007 (S.1408) , which would create financial incentives for hospitals and other qualified providers to adopt health information technology (IT). Specifically, S.1408 would create a five-year, $4 billion competitive grant program for hospitals, physicians, and other designated providers to purchase, lease, and install computer software and hardware; make improvements to existing software and hardware; purchase or lease communications capabilities necessary for clinical data access, storage and exchange; and purchase, lease, subscribe, integrate, or service clinical decision support tools.

The legislation would also pay qualified providers a higher fee for items and services that use health IT to improve the quality and accuracy of clinical decision-making, compliance, healthcare delivery, and efficiency for patients with chronic conditions. Both Stabenow and Snowe introduced similar legislation during the 109th Congress, but no action was taken. Copies of the legislation are available on the congressional Web site, THOMAS, at Sen. Stabenow’s press release is also available online.

Bipartisan Diabetes Management Legislation Introduced

New York Reps. Elliott Engel (D) and Vito Fosella (R) joined Sens. Hillary Clinton (D-N.Y.) and Susan Collins (R-Maine) in May to introduce legislation that would provide research funding to the Centers for Disease Control and Prevention (CDC) to improve early detection, prevention, and access to quality care for diabetes. The legislation, titled Diabetes Treatment and Prevention Act of 2007 (H.R.2241 and S.1343), directs the CDC to ‘partner’ with state and local health departments to gather information on the number of people that have been screened for diabetes and the availability of interventions to prevent the disease. More information on both bills is available on the congressional Web site, THOMAS.

IOM to Study Genetic Testing

When the Senate passed the FDA Revitalization Act (S.1082) in early May, it included a measure proposed by Sen. Barak Obama (D-Ill.) requiring the Institute of Medicine (IOM) to conduct a study detailing and recommending improvements to the current regulatory environment for genetic testing. As of press time, the legislation had been sent to the House of Representatives for consideration. Sen. Obama called for a similar IOM study in the Genomics & Personalized Medicine Act (S. 976), which he introduced with Sen. Richard Burr (R-N.C.) in March. Additional information on these bills is available on the congressional Web site, THOMAS.

CMS Proposes New Hospital DRG System

CMS has proposed a restructuring of the current diagnosis related groups (DRGs) payment system. The agency would replace the existing 538 DRGs with 745 new medical severity (MS) DRGs. The new diagnosis groups would more accurately take into account the severity of the patient’s condition, thereby barring hospitals from ‘cherry-picking’ the healthiest and most profitable patients, according to CMS.

Under the plan, CMS will no longer pay hospitals for the additional costs associated with hospital-acquired conditions and infections. In addition, the agency is proposing that hospitals report on six new quality measures in FY08—bringing the number to 27—in order to get the full market basket update in FY09. This means that under this restructuring, hospitals serving more severely ill patients could receive more funding; while conversely, those treating the less ill will realize less. Additional information is available on the CMS Web site.