American Association for Clinical Chemistry
Better health through laboratory medicine
May 2008 Clinical Laboratory News: Regulatory Profiles

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May 2008: Volume 34, Number 5

San Diego Labs Win Competitive Bidding Challenge

A U.S. District Court Judge for the Southern District of California has granted a preliminary injunction delaying the CMS’s competitive bidding demonstration project in the San Diego area. Judge Thomas J. Whelan’s order prevents CMS from announcing winners, otherwise implementing and carrying out the demonstration project in San Diego, and disclosing any information included in the bid applications.

In reaching the decision, the court found that Sharp Healthcare, Scripps Health, and Internist Laboratory had shown the competitive bidding measure would cause irreparable harm, including substantial economic injury to the labs and danger to patients. Judge Whelan noted that the labs would have to set up costly procedures to determine which tests would be included and which would not.

The judgment stops the project for the time being, but the next steps are unclear. The decision by the court may allow Congress to halt the competitive bidding demonstration project for good, or there may be a full trial, after which Judge Whelan will make a final, permanent ruling.

In January, the labs sought a temporary restraining order (TRO) against CMS to delay or stop the project on grounds that it would harm vital laboratory testing services for thousands of Medicare beneficiaries. In February, the judge denied the TRO because winners of the project had not yet been chosen and, therefore, no one had been harmed.

AACC has opposed the CMS competitive bidding demonstration and encourages laboratorians to contact their elected officials and regulators to express their opinions on this issue. Send letters to your elected senators and congressional representatives via the AACC’s Advocacy Network on the AACC Web site.

NIH Seeks Comments on Public Access Policy

Members of the public have until May 31 to comment on the NIH’s proposed policy that would require its grantees to publish the results of their investigations in its public access forum. The Public Access Policy ensures that the public has access to the published results of NIH funded research by requiring NIH-funded scientists to submit journal articles from their research to the digital archive PubMed Central.

As of April 7, 2008, authors had to submit all articles arising from NIH-funded research to PubMed Central upon acceptance for publication. Beginning on May 25, 2008, NIH applications, proposals, and progress reports must also include the PubMed Central reference number when citing an article that falls under the policy and is authored or co-authored by the investigator, or arose from the investigator’s NIH grant. To submit a comment, go to the NIH Web site.

CMS Web Site Offers Information on Hospital Quality Measures

The CMS Hospital Compare Web site allows the public to compare hospitals in their communities based on specific medical conditions or surgical procedures. Consumers also can conduct a general search for hospitals within a specific geographic area. The CMS site provides information on 26 quality measures, which include process of care measures—the degree to which a hospital provides care—and outcome measures—results of the care beneficiaries received while a patient. The agency plans to add information about the number of certain elective hospital procedures and what Medicare pays for those services.

The agency said the Web site offers consumers three critical elements—quality information, patient satisfaction survey data, and pricing information for specific procedures—allowing them to make effective decisions about the quality and value of the health care available to them locally. This, CMS added, gives people the ability to make better choices and lower their health care costs.

This summer CMS will add an additional outcome mortality measure for pneumonia, which will accompany mortality measures for heart attack and heart failure. To view the site, go to the HHS Web site.


Expanded Coverage for PT/INR Monitoring

CMS has expanded Medicare coverage for home blood testing of prothrombin time /INR to include beneficiaries who are using warfarin for chronic atrial fibrillation or venous thromboembolism.

Medicare Part B will now cover and pay for meter training, equipment, and supplies for all long-term warfarin users who monitor their prothrombin time at home with a portable handheld meter. Previously, Medicare reimbursed these expenses only for at-home patients who had mechanical heart valves. To read the CMS decision memo, go to the CMS Web site.

House Panel Approves Newborn Screening Measure

The House Energy and Commerce Subcommittee on Health has passed H.R.3825, the “Newborn Screening Saves Lives Act of 2008.”  The revised bill would provide grants to states and other entities to “enhance, improve, or expand” the ability of state and local public health agencies to provide newborn screening, as well as educate and train laboratory personnel, and improve the coordination of care of congenital, genetic and metabolic disorders. The measure also provides funding to evaluate the effectiveness of screening programs and establishes a clearinghouse of information on newborn screening for parents, family members, and other interested parties. To read the revisions to the bill go to the subcommittee web site. To read more about the bill, go to the Congressional Website.

Senate Adds Billions to Proposed NIH Budget

The U.S. Senate has passed a resolution that adds $2.1 billion to the President’s proposed NIH budget of $29.5 billion for 2009. That funding is in addition to about $950 million that a Senate Budget committee added earlier to the budget resolution.

SACGHS Submits Recommendations to HHS

The Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) will submit its final report to the HHS Secretary by April 30, the group announced at its most recent meeting. Andrea Ferreira-Gonzalez, PhD, who chaired the task force drafting the document, reported that 65 individuals and organizations provided feedback on the draft document and that comments covered such areas as strong support for increased proficiency testing (PT), support for a mandatory test registry, and support for FDA oversight.

During two days of rigorous discussion, SACGHS members reached agreement on a number of recommendations, including: creation of a mandatory, Web-based registry for all laboratory developed tests; barring laboratories without a CLIA certificate from receiving Medicare or Medicaid reimbursement; mandating PT for all non-waived tests for which it is available; hiring additional CMS staff and providing genetic training to its inspectors; and creating a private-public entity to assess the clinical utility of genetic tests. To view a Webcast of the meeting, go to the NIH Web site.