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June 2011
Policy and Advocacy
New Bills Focus on Incentives for Antibiotic Development and Home Infusion Therapy Coverage

Two bipartisan bills recently introduced in Congress represent important first steps in addressing two key IDSA policy priorities: spurring the development of new antibiotics and extending coverage of home infusion therapy to Medicare beneficiaries.

The Generating Antibiotics Incentives Now (GAIN) Act (H.R. 2182), introduced by U.S. Rep. Phil Gingrey (R.-Ga.) in the House of Representatives in June, is intended to encourage pharmaceutical companies to create desperately needed new antibiotics. Co-sponsors include Reps. Gene Green (D-Texas), Diana DeGette (D-Colo.), Anna Eshoo (D-Calif.), Mike Rogers (R-Mich.), Ed Whitfield (R-Ky.), and John Shimkus (R-Ill.). IDSA supports the bill as a foundation for moving forward and believes it is an excellent starting point for discussing the incentives needed to spur antibiotic and related diagnostics development. IDSA shared its support and additional ideas for the legislation in a letter (PDF) to Rep. Gingrey. (See related press release.)

Also this month, lawmakers introduced the Medicare Home Infusion Therapy Coverage Act of 2011, which would give Medicare beneficiaries access to the same life-saving drug therapies in the home setting that most privately insured patients already enjoy. Sen. Olympia J. Snowe (R-Maine) introduced the bill (S. 1203) in the Senate; Rep. Eliot L. Engel (D-N.Y.) did so in the House (H.R. 2195). Both versions would also require high quality standards to ensure the safe and effective provision of home infusion therapies, which can reduce hospital stays, limit complications, and lower health care costs.

“Unfortunately, today, we have two standards of care,” said IDSA President-Elect Thomas Slama, MD, FIDSA, in an IDSA press release about the legislation. “Patients who have good private health insurance usually have this benefit covered. Most patients who have fee-for-service Medicare do not.” Click here for more information about IDSA’s advocacy in support of Medicare coverage of home infusion therapies.

In other policy and advocacy news:

  • IDSA recently joined the Pew Charitable Trusts and other groups in a letter (PDF) asking the Food and Drug Administration to prohibit extra-label use of cephalosporins in food-producing animals, noting the link to human health. Public health authorities in Canada recently showed that a voluntary extra-label ban on cephalosporins in poultry hatcheries resulted in a reduction in cephalosporin resistance in Salmonella isolates from sick humans. Once the voluntary ban was lifted, resistance rose again. According to the Centers for Disease Control and Prevention, approximately 3 percent of the estimated 1 million human Salmonella cases in the U.S. each year are resistant to cephalosporins. The groups believe that an extra-label ban in the U.S. could help.
  • In a June letter (PDF), the Society supported the National Institute of Allergy and Infectious Diseases’ (NIAID) plan for a new clinical trials network primarily focused on bacterial antibiotic resistance. IDSA also proposed the establishment of an ID clinical specimen repository, which could be housed at NIAID and linked to clinical trials conducted through the network and other sites.
  • The Society responded to a recent Medicare regulation that proposed four additional exemption categories to the E-Prescribing (eRx) Incentive Payment Program. The exemptions are designed to allow eligible professionals who have difficulty meeting the eRx reporting requirements to avoid a payment penalty.  IDSA’s comments (PDF) are available online.
  • The Centers for Medicare and Medicaid Services (CMS) has reconsidered a potentially burdensome paperwork rule that would have required physicians to provide their signatures on requisitions for laboratory tests. In late June, CMS took the first step in retracting the policy by issuing a proposed rule. The signature requirement was originally included in Medicare’s 2011 physician fee schedule but never enforced. Several lawmakers and the American Medical Association had criticized the policy, and CMS acknowledged in late March that physicians, laboratories, and other providers were having difficulty complying with the requirement, according to Inside Health Policy, and postponed the rule.  See the April 2011 IDSA News for additional information.

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