In This Issue...


Senate HELP Committee Approves Device User Fee Legislation

The Senate Health, Education, Labor and Pensions (HELP) Committee recently passed legislation extending the current medical device user fee statute. The legislative changes are part of a more comprehensive bill, the Safety and Innovation Act, that also covers user fees for prescription drugs, generic drugs and pediatric drugs and devices. Some of the medical device provisions include:

  • Reauthorizing the medical device user fee program through FY’2017 -- collecting $595 million in fees for the FDA;
  • Allowing the HHS Secretary to change the classification of a device, if there is new information, by administrative order rather than by regulation;
  • Permitting the HHS Secretary to require, as a condition of pre-market approval, a post-market study of the device; and
  • Streamlining the de novo process to allow the Secretary to classify a device without a predicate as low to moderate risk without first obtaining a not substantially equivalent designation.

The House Energy and Commerce Committee plans to mark up its draft version of this legislation early this month. If you would like a description of the Senate HELP user fee bill, please visit the committee Web site

GAO Asserts CMS Doing Better against Medicare Fraud

In April 2012, the Government Accountability Office (GAO) issued a report entitled, “Important Steps Have Been Taken, But More Could Be Done to Deter Fraud,” stating that the Centers for Medicare and Medicaid Services (CMS) has improved a number of screening processes to prevent fraud, including its enrollment process for providers and its pre-payment review mechanisms for limiting overpayments. But the investigative agency suggested that CMS still could do a better job identifying fraudulent trends on the post-payment side. A copy of the report is available on the GAO Web site.

Medicaid Oversight Needs Improvement

In another April 2012 GAO report, entitled, “Federal Oversight of Payments and Program Integrity Needs Improvement,” the investigative agency asserts that CMS needs to improve its oversight of federal Medicaid contractors; program auditors are failing to identify fraudulent payments. In fact, contractor efforts to recoup overpayments during the past three years have resulted in a net loss to the program of nearly $21 million. For more on the study, please visit the GAO Web site.

High Rate of Payment Denials Overturned Upon Review

Two government reports released this spring indicate that providers are winning a high rate of appeals involving Medicare claims denials. A CMS Report to Congress, “Implementation of Recovery Auditing at the Centers for Medicare and Medicaid Services,” indicates that 46 percent of Medicare claims appealed in 2010 under the Recovery Audit Contractor (RAC) project were won by the provider. Similarly, a broader HHS Office of the Inspector General review of 2010 Medicare fee-for-service data, “Pilot Project to Obtain Missing Documentation Identified in the Fiscal Year 2010 CERT Program”, discloses that 34 percent of the denied claims reviewed in the study were overturned. For a copy of the RAC report, please visit CMS . For a copy of the OIG document, please go to its Web site.

OSHA’s Ability to Protect Workers is Questioned

A GAO report, “Workplace Safety and Health: Multiple Challenges Lengthen OSHA’s Standard Setting,” was recently released at a hearing conducted by the Senate HELP panel. The document questions whether the Occupational Safety and Health Administration (OSHA) is too cautious in issuing federal regulations to protect American workers. According to the April 2012 report, it takes the federal agency seven years, on average, to develop and implement federal health and safety regulations.

The Chair of the HELP Committee, Senator Tom Harkin (D-IA), commented on the report, saying“…the process for setting safety standards at OSHA is broken. Even when the evidence is undeniable that our workers are dying from workplace hazards, OSHA still takes an eternity to issue a new safety rule. While reasonable safety rules are delayed to provide never-ending opportunities for stakeholder input, workers’ lives and livelihood are at risk. It is simply unconscionable that workers must suffer while an OSHA rule is mired in bureaucracy.”

The report further indicates that the number of final rules promulgated by the agency dropped by more than half in the 2000s after releasing more than 20 standards during both the 1980s and 1990s. The HELP committee has not yet indicated what actions it may take to improve agency performance. A copy of the GAO report is available on its Web site.

PCORI Amends Draft Research Agenda

On April 25th, the Patient-Centered Outcomes Research Institute (PCORI) approved changes to its draft research agenda after receiving more than 400 public comments on the document. The changes further defined the Institute’s research interests in key areas, such as access to care, patients with rare diseases, and improving health literacy. A revised version of PCORI’s National Priorities and Research Agenda will be published May 21st on its Web site.