September 2008 Clinical Laboratory News: Regulatory Profiles

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September 2008: Volume 34, Number 9


 Comparative Effectiveness Bill in Senate


A new bill introduced in the Senate would create a hub for researchers to evaluate clinical research—for drugs, devices and surgical procedures—in a bid to lower healthcare costs.

The bill, S 3408, would create the nonprofit Health Care Comparative Effectiveness Research Institute. It would work with HHS, AHRQ and NIH, as well as drug and device makers, patients, and clinicians, to deliver peer-reviewed research studies about healthcare effectiveness. A private, 21-member Board of Governors, comprising the HHS secretary, the director of AHRQ, the director of the NIH, as well as representatives of patients, physicians, public health agencies, public payers, private payers, the pharmaceutical industry, device manufacturers, nonprofit health research organizations and quality improvement organizations, would govern the institute.

Senate Finance Committee Chair Max Baucus (D-Mont.) and Senate Budget Committee Chair Kent Conrad (D-ND) sponsored the bill. The institute would cost $5 million starting in 2010 and be funded by taxpayer money.


House Committee Passes Health IT Bill


The House Energy and Commerce Committee unanimously approved legislation—HR 6357, sponsored by Rep. John Dingell (D-Mich.)—designed to promote faster adoption of electronic health records (EHRs). The Protecting Records, Optimizing Treatment and easing Communication Through Healthcare Technology [PRO(TECH)T] Act of 2008 aims to promote national use of EHRs by 2014.

The Act would provide $560 million in grants and loans for healthcare providers, particularly in small and rural practices and those serving the underserved, to acquire EHR systems. If approved, the PRO(TECH)T Act would require HHS to disclose more fully how it resolves complaints of HIPAA privacy and security violations.

The PRO(TECH)T Act also would establish a process for developing, recognizing, and harmonizing technical standards for health IT, and promote the adoption of such standards by HHS.

To view the bill, go online.



      AHRQ, AARP Join Forces for Health, Prevention Effort


The Agency for Healthcare Research and Quality (AHRQ) and the AARP have teamed up to release two new checklists designed to help men and women over the age of 50 learn what they can do to stay healthy and prevent disease.

The two organizations also released an accompanying wall chart, the Staying Healthy at 50+ timeline, which provides information about recommended preventive services. These three publications are: “Men: Stay Healthy at 50+: Checklists for Your Health; Women: Stay Healthy at 50+: Checklists for Your Health; and The Staying Healthy at 50+ Timeline. Each shows at a glance the evidence-based recommendations from the U.S. Preventive Services Task Force regarding screening tests, preventive medicines, and healthy lifestyle behaviors.

The Checklists for Health brochures, available in English and Spanish, are designed to help patients and clinicians discuss necessary preventive screening tests.


P4P Programs May Not Affect Quality of Care


A new study concludes that pay for performance programs—also known as P4P programs—offer little to no impact on quality of care. The study compared 81 Massachusetts physician groups eligible for quality incentives with 73 that lacked eligibility, and the performance of some 5,350 physicians between 2001 and 2003. The study was published in the July/August issue of Health Affairs.

Bonuses ranged from $200 to $2,500 per quality measure for an individual physician, depending on the health plan.

The researchers found that during this period overall performance improved on almost three-quarters of such preventive care measures as HbA1c testing, breast cancer screening, and well-child visits. However, the scientists observed that earning a bonus for providing guideline-based care made no difference. Statistically, the physicians’ performance measures were indistinguishable.

View the abstract online.

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