In This Issue...


Supreme Court Upholds Health Care Law

On June 28th, the Supreme Court issued a 5-4 decision upholding the 2010 Affordable Care Act (ACA) to extend health insurance to 30 million Americans. The pre-ruling focus was on the question of whether Congress could compel individuals to purchase health insurance or if that requirement was a function of the state. The Court ruled that Congress could. One area of the law in which the Court did intervene was the expansion of Medicaid.

Under ACA, Congress extended Medicaid eligibility to all Americans with incomes up to 133 percent of the poverty rate or, approximately 17 million Americans. Since Medicaid is a joint federal-state program, states would have to agree to participate in this expansion. If they did, the federal government would agree to pay 100 percent of health costs for new recipients for three years, then, gradually reduce its contribution to 90 percent.

Many states complained that even with the generous federal payments, it would still cost billions of dollars they do not have. Twenty-six states challenged the Medicaid provision, because the bill requires them to participate in the expansion or lose all federal Medicaid funding for both existing and new beneficiaries. The Supreme Court decision permits states to opt out of the expansion without jeopardizing their current status in the program.

Ironically, this provision may significantly impact the ability of the Administration to meet the goals of ACA. If those states opposing Medicaid expansion follow through on their threat not to participate, many individuals qualifying for Medicaid will not be eligible for federal subsidies to purchase health insurance through the state exchanges. Only individuals with incomes over 100 percent of the poverty rate are eligible for such assistance. If states opt out, the only way for Congress to address this issue will be to enact additional legislation, an unlikely event at this point.

If you would like to read the text of the Supreme Court decision, please visit the MSNBC Web site.

Congress Passes Medical Device User Fee Legislation

By overwhelming numbers, the House of Representatives and the Senate passed the medical device user fee legislation to extend the user fee program for another five years. The legislation will:

  • Reduce total review times for device submissions;
  • Streamline the de novo process;
  • Reform the conflict-of-interest rules for advisory committees;
  • Require the FDA to withdraw its draft guidance of 510(k) modifications.

The bill has been sent to the President, who is expected to sign it into law. If you would like a copy, please go the Government Printing Office Web site.

AHRQ White Paper on Medical Device Registries

The Agency for Healthcare Research and Quality (AHRQ) is seeking public comment on a white paper, "Registries for Evaluating Patient Outcomes: A User’s Guide," which outlines the challenges and potential benefits of creating Medical Device Registries. The Agency is particularly interested in getting patient input on “medical device performance in a real world setting.” AHRQ is accepting comments on the draft white paper through July 26th here. A copy of the white paper is available on the agency Web site.

AHRQ Draft Report on Screening and Diagnosing Gestational Diabetes Mellitus

AHRQ is seeking public input on its draft report, "Screening and Diagnosing Gestational Diabetes Mellitus." The objectives are to:

  • Identify properties of screening tests for gestational diabetes mellitus;
  • evaluate benefits and harms of screening; and
  • determine the effects of treatment for gestational diabetes mellitus.

The draft study concludes:

  • “While evidence supports a positive association with increasing plasma glucose on a 75 g or 100 g oral glucose tolerance test and macrosomia and primary cesarean section, clear thresholds for increased risk were not found.
  • The 50 g oral glucose challenge test has high NPV but variable PPV. Treatment of gestational diabetes mellitus results in less preeclampsia and macrosomia. Current evidence does not show that treatment of mild gestational diabetes mellitus has an effect on neonatal hypoglycemia or future poor metabolic outcomes.
  • There is no evidence of harm to treating gestational diabetes mellitus other than an increased demand for services. Research is needed on the long-term metabolic impact of gestational diabetes and its treatment on offspring, and the “real world” impact of gestational diabetes mellitus treatment on care utilization.”

If you would like to see the entire report, and/or comment, please visit the AHRQ Web site. The agency is accepting comments through July 13th.