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Joint Commission Seeking Comments on National Patient Safety Goal

The Joint Commission is seeking public comments on a proposed patient safety goal requiring hospitals to initiate a program to identify “tests, treatments, and procedures that, when overused, may result in harm to patients” to take effect on January 1, 2013. Hospitals would be allowed to select the test, treatment or procedure they want to evaluate or select one of following five topics:

  • Early induction of labor; for example, elective induction of preterm deliveries for pregnancies of 39 weeks gestation or less in patients with no known medical conditions that predispose to such delivery;
  • Insertion of tympanostomy tubes; for example, the insertion of tympanostomy tubes in children with otitis media and bilateral effusions of less than 60 days and without the presence of other symptoms;
  • Red blood cell transfusions; for example, packed red blood cell transfusions in patients with hemoglobin of 12 grams or more without clinical signs of hemodynamic instability;
  • Percutaneous coronary interventions; for example, coronary stenting or balloon angioplasty for coronary stenosis of 40% or less; and
  • Diagnostic ionizing radiation; for example, use of CT scans before considering ultrasound for patients presenting to the emergency department with a primary complaint of abdominal pain.

The Joint Commission will be accepting comments through January 24th. The proposal is available on the Accreditation’s Web site.

Bipartisan Plan To Allow Medicare Competition

Senator Ron Wyden (D-OR) and Representative Paul Ryan (R-WI) recently released a proposal, the “Guaranteed Choices to Strengthen Medicare and Health Security for All: Bipartisan Options for the Future,” to provide seniors with greater options for obtaining health care. Under the plan, Medicare beneficiaries would have the choice of staying with the federal insurance plan or accepting a voucher to purchase insurance from a Medicare-approved private plan. All participating private plans would be required to offer benefits at least as comprehensive as Medicare’s. The sponsors hope that additional competition will “spur a wave of innovation to lower health-care costs and provide higher-quality health care.” The proposal would also set a cap on Medicare’s rate of growth; if this rate is exceeded, Congress will be required to “reduce payments to providers, drug companies, or others who may be responsible for escalating costs.” A copy of the plan is available on Senator Wyden’s Web site.

Senators Promote Device Safety

Senators Herb Kohl (D-WI), Charles Grassley (R-IA) and Richard Blumenthal (D-CT) recently introduced legislation, the “Medical Device Patient Safety Act,” to strengthen FDA authority over ‘faulty’ devices. Specifically, the bill would give the agency new powers to assess and act on device recalls and will require manufacturers to agree to the collection of post-market data as a condition for clearing a 510(k) application. The sponsors hope to include the measure in the FDA user fee reauthorization bill, to be taken up this year. If you would like a summary of the legislation, please visit Senator Grassley’s Web site.

FDA Releases Substantial Equivalence Guidance

On December 27, 2011, the Food and Drug Administration (FDA) issued a draft guidance, “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications,” outlining the process for manufacturers to get new devices cleared. The updated guidance advises on the appropriate use of multiple predicates, the process for determining whether a device has a new intended use, and when different technological characteristics could raise questions about safety and effectiveness. The FDA will be accepting comments through April 27th. The guidance is available on the agency Web site.