In This Issue...


The House and Senate Pass FDA User Fee Bill

The Senate passed S.3187, the Food and Drug Administration Safety and Innovation Act, on May 24th, which reauthorizes the medical device user fee program for another five years. The legislation also includes a number of agency reforms, such as:

  • Allowing the agency to change a device’s classification by administrative order rather than regulation;
  • Requiring the FDA to provide a scientific and regulatory rationale for its review decisions;
  • Streamlining the de novo process; and
  • Requiring the agency to work with its foreign counterparts to facilitate the use of foreign data for pre-market reviews.

The House passed its version (see the May 24th GAU for more on the House bill) of the user fee bill on May 30th. The House and Senate will meet in conference to work out a compromise measure. The goal of the congressional leadership is to send a final bill to the president prior to July 4th. If you would like a copy of the Senate or House (H.R.5651) bills, please go to the congressional Web site, THOMAS.

House Passes Bill Repealing Medical Device Tax

On Thursday, June 7th, the House of Representatives passed legislation, H.R.436, the Health Care Cost Reduction Act of 2012, which would repeal the 2.3 percent excise tax on medical devices enacted as part of health care reform. The vote in favor of repeal was 270-146, with nearly 40 Democrats supporting the measure. The congressional Joint Committee on Taxation estimates that the device tax would raise $29 billion over 10 years. Please visit the congressional Web site THOMAS, to see a copy of the bill.

CMS Failed to Recoup Millions in Overpayments

On May 24th, the HHS Office of the Inspector General released an audit, “Obstacles to Collection of Millions in Medicare Overpayments,” that examined the Centers for Medicare and Medicaid Services efforts to recoup unwarranted Medicare payments. The OIG found that the government insurer only collected $84 million out of $416 million in overpayments identified by the investigative group. The Auditors recommended that CMS take a number of actions, including:

  • Pursue legislation to extend the statute of limitations for recovering overpayments from four to ten years;
  • Verify that the $84 million reported recovered by CMS was actually collected;
  • Collect the amounts specified by the OIG; and
  • Provide specific guidance to contractors regarding the timeframe they have for collecting overpayments.

A copy of the report, A-04-10-03059, is available on the OIG Web site.

FDA Announces Public Meeting on Hospital Glucose Sensors

The Food and Drug Administration is conducting a public meeting on June 25, 2012, to get input regarding the clinical study design and performance of hospital glucose sensors intended for use in point of care settings. Among the questions to be discussed are:

  • Who is the likely intended use population for these devices and how will they be used in patient management? What are the study considerations for evaluating the devices in these different populations?
  • How does the intended use of the device affect the design of the clinical studies and the evaluation and adequacy of device performance? For example, are the accuracy needs for a device used to monitor trends over time different from the accuracy needs of one where the individual glucose results are used to replace discrete glucose measurements? Is greater accuracy needed when the device is used in certain populations? What metrics can be used to evaluate whether or not results from these devices are sufficiently accurate and reliable for the proposed intended use(s)?
  • What conditions, medications, or therapies have the potential to cause interference and require evaluation? What kinds of studies/models are appropriate to evaluate interference?
  • Differences in glucose concentrations may be observed when testing arterial and venous blood samples from the same patient. How can the potential differences in blood glucose concentrations be addressed when conducting the clinical studies?

If you are interested in getting more information about this meeting, or attending, please visit the FDA Web site.

AHRQ Releases Draft Study on Assessing Impact of Iron Status on Kidney Patients with Anemia

The Agency for Healthcare Research and Quality (AHRQ) recently released a draft comparative effectiveness report entitled, “Laboratory Biomarkers for Assessing Iron Status and Managing Iron Deficiency in Late Stage Chronic Kidney Disease Patients with Anemia,” which evaluates the use of newer versus classical laboratory biomarkers of iron status as part of the management strategy for anemia in patients with CKD stages 3–5.

The study, suggested by AACC, concludes that “all currently available laboratory biomarkers of iron status (either newer or classical markers) do not have a good predictive ability when used singly to determine iron deficiency as defined by a response to iron challenge test. However, it may be that CHr and %HYPO have better predictive ability for a response to IV iron treatment than classical markers (TSAT <20 or ferritin <100 ng/mL) in HD CKD patients.

In addition, results from two RCTs showed a reduction in the number of iron status tests and resulting IV iron treatments administered to patients whose iron management was guided by CHr, compared to those guided by TSAT or ferritin. These results suggest that CHr may be a suitable alternative marker of iron status for guiding iron treatment, and could potentially reduce the frequency of iron testing and potential harms from IV iron treatment.”

To view and comment, please visit the AHRQ Web site.

AHRQ is accepting comments on the study through June 18th. Let me know if you have any questions.

USPSTF Recommends Against Routine PSA Testing

The United States Preventive Services Task Force (USPSTF) recently published its final recommendation regarding routine prostate-specific antigen (PSA) screening tests in the Annals of Internal Medicine. The panel gave the evidence in support of routine PSA testing a grade of “D,” meaning that “there is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits.” The recommendation is not a surprise, since the USPSFT released a draft last fall making similar arguments. A copy of the report is available on the Annals Web site.