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May 5, 2008


May 5, 2008

In April,

the Centers for Medicare and Medicaid Services (CMS) released a proposal to expand the list of hospital acquired conditions (HAC) that Medicare would not reimburse. This policy is often referred to as the "never events" policy. Under the new policy, these "never events" or hospital acquired conditions (HACs) would be tracked by hospitals and providers. As part of the President's FY09 budget proposal, hospitals would be required to report HACs or face reduced Medicare reimbursement. Furthermore hospitals would be prohibited for billing for, and Medicare would not reimburse for HACs.

  • CMS has released, for discussion, a proposed list of ten HACs or "never events" for public comment, including:
  • Surgical Site Infections Following Specific Elective Surgeries
  • Legionnaires' Disease
  • Extreme Glycemic Aberrancies
  • Iatrogenic Pneumothorax
  • Delirium
  • Ventilator-Associated Pneumonia (VAP)
  • Deep Vein Thormbosis (DVT)/Pulmonary Embolism (PE)
  • Staphylococcus aureus Septicemia
  • Clostridium Difficile-Associated Diseases (CDAD)

In addition to the above proposed never events, CMS is requesting comments on Methicillin-Resistant Staphyloccus aureus (MRSA). In the proposal, CMS recognizes the MRSA is not reasonably preventable by adherence to published evidence-based guidelines and therefore does not fit the typical "never events" portfolio. However, due to MRSA public health impact, CMS is seeking comments on appropriateness of developing payment policy to address MRSA in the hospital setting.

Clearly there are a number of pulmonary and critical care related conditions, making this proposal of unique interest to the American Thoracic Society. The ATS will review the CMS proposal and provide comments on the appropriateness of the proposed "never events."

Clean Air


EPA Proposes New Airborne Lead Standard


For the first time since 1978, the Environmental Protection Agency is proposing to tighten the lead airborne standard. EPA announced its proposal to lower the standard for airborne lead from the current standard of 1.5 mg/m3 to a stricter standard within the range of 0.10 to 0.30 micrograms per cubic meter. EPA is also accepting comments on proposals lower than 0.10 micrograms per cubic meter and as high as 0.50 micrograms per cubic meter. While not part of the EPA proposal, EPA is interested in receiving comments on the appropriateness of using the PM10 standard as the lead standard.

EPA will be holding public hearings on June 12 in St. Louis, MO and Baltimore, MD to collect community input on the proposed lead standard. The public comment period will close 60 days after the proposed rule is officially published in the federal register.

EPA estimates that 12 counties currently would fail to meet the 0.30 mictrograms per cubic meter standard while 23 counties would fail to meet the stricter 0.10 standard. In announcing the proposal, EPA also noted that the monitoring network for lead is insufficient and is recommending that airborne lead monitors be placed near known lead sources and population centers over 1 million people.

The ATS will closely review the proposed rule for lead and submit comments on the proposed EPA standard. By court order, the final rule must be issue by September 15, 2008.



NIH Reiterates
Mandatory Manuscripts Submission Policy


In April, the National Institutes of Health re-issued policy regarding its mandatory policy that all peer reviewed articles supported with NIH funds must be deposited in the NIH's PubMed Central within 12 months of official publication. The NIH policy is a result of legislation passed by Congress requiring public posting of all manuscripts funded in whole or in part by NIH.

NIH now requires, "that all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine's PubMed Central (PMC) an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication, provided that the NIH shall implement the public access policy in a manner consistent with copyright law."

Under the NIH policy, manuscript authors are expected to

* Remain in full compliance with all publishing or copyright agreements.
*Submit all supplemental and graphic elements related to the final peer-reviewed article.
*Submit - or have submitted for them - NIH manuscripts to NIH PMC.
*Include the PMC or NIH manuscript submission reference number for all applications, proposals, and progress reports when citing related articles that emerge from NIH funded research, beginning May 25, 2008.

Authors who publish in the American Journal of Respiratory and Critical Care Medicine (AJRCCM), the American Journal of Respiratory Cell and Molecular Biology (AJRCMB) will automatically comply with NIH policy.

Clinical Practice


ATS Submits Recommendations on UnitedHealthcare TB Testing Policy


This week, the ATS and ACCP provided joint recommendations on tuberculosis (TB) diagnostics to health insurer UnitedHealthcare. The company invited the ATS and ACCP to comment on its newly updated coverage policy drafted to reflect new Centers for Disease Control and Prevention (CDC) diagnostic guidelines on TB testing. In their letter, the ATS and ACCP commended UnitedHealthcare for updating its coverage policy, including coverage of the Quantiferon-TB Gold blood test for latent TB infection, and recommended future revision of UnitedHealthcare's policy to include a new TB diagnostic test, the T-Spot TB test, which is expected to gain FDA approval within the next year.



Oklahoma Senator Stalls TB Bill


Senate passage of the domestic tuberculosis (TB) bill, the Comprehensive TB Elimination Act, S. 1551, sponsored by Sens. Brown (D-OH) and Hutchison (R-TX), has stalled due to opposition from Sen. Tom Coburn (R-OK). The bill passed the Senate Health, Education, Labor and Pensions (HELP) Committee, chaired by Sen. Kennedy (D-MA), unanimously in November 2007, and was this month placed on the Senate floor vote calendar. Sen. Coburn is on record for opposing legislation that deals with specific diseases rather than overall health research and services, and has indicated his opposition to S. 1551 for this reason. Unless Sens. Brown, Hutchison and Coburn can find a compromise on moving it forward, Sen. Brown will attempt to attach the bill to larger public health legislation to be considered later this summer.
Despite the delay on the Senate bill, the companion House bill, H.R. 1532, sponsored by Reps. Green (D-TX) and Wilson (R-NM), continues to gain support. The bill, now with 50 bipartisan cosponsors, is awaiting action by the House Energy and Commerce Committee's Health subcommittee, chaired by Rep. Pallone (D-NJ). ATS members are asked to contact their Representative and two Senators to request cosponsorship of the TB bill, S. 1551/H.R. 1532. Visit the ATS website for direction on how to do this at: http://www.thoracic.org/sections/about-ats/advocacy/take-action-now.html

Points of Contact

Gary Ewart Senior Director, Government Relations
Nuala Moore Senior Legislative Representative
Joe Kirby DC Office Administrator