A Medical Device Daily

FDA's public image problems must surely be the stuff of public relations legend by now, and the agency recently turned to a PR firm in an effort to turn its image problems around. Unfortunately, the agency attempted to contract with a firm in a roundabout fashion while sidestepping the usual requirements to open the contract to bidding.

According to a story appearing in yesterday's edition of the Washington Post, Mildred Cooper, a consultant working as a civil servant with FDA on a two-year contract, was tasked with making arrangements for the $300,000 contract and contacted Qorvis Communications (Washington), a firm she had previously worked with during a stint at Luna Innovations (Roanoke, Virginia). Her eventual contact at Qorvis, Don Goldberg, was said to have worked in the crisis management team in the Clinton administration.

What is not clear is who at FDA knew of the arrangement that awarded the full contract to a minority-owned firm, Alaska Newspapers (AN; Anchorage, Alaska), presumably chosen because its minority ownership allowed the contract to go out without bids. AN would then have handed much of the project off to Qorvis, and the Washington Post story said that Goldberg told the Post that he understood that Cooper "was working with the commissioner and the chief of staff" and that he was aware that "it was not appropriate to hire Qorvis directly."

Goldberg's discussions with a consultant who had previously worked with Qorvis, James Dunn, led to the idea of the arrangement with AN, which the article said has "a small public relations office" in addition to its publishing business.

FDA's deputy commissioner, John Dyer, was quoted in the Post article as having said he had ordered an investigation into the matter and that the agency "has full confidence in the integrity of its contract procedures as verified by independent third-party reviews conducted several times a year."

According to the Post, one FDA official told the paper that AN "had pledged in writing to do more than half the work," but that vow seems to have had little effect, and Rep. John Dingell (D-Michigan), has promised more congressional investigations into the agency's workings. Dingell is the chairman of the House Energy and Commerce Committee, which has substantial jurisdiction over the agency's operations. Dingell has been quoted as saying: "This sham of a contract calls into question the integrity of federal contracts awarded to small businesses and Alaska Native corporations."

CMS seeking nominees for DME panel

The Centers for Medicare & Medicaid Services exhibits little loss of appetite for its bidding program for durable medical equipment (DME) as indicated by the Oct. 1 statement that the agency is soliciting the public for nominees to an advisory panel that deals with operational issues for the program, the Program Advisory and Oversight Committee (PAOC).

Not all the terms of the current members of the committee have expired, but CMS explained that it is terminating the current membership of the committee because the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) "delayed implementation of and made certain changes to the competitive bidding program," which knocks the program offline until December 31, 2011.

Acting CMS administrator Kerry Weems said in the statement that the agency "look[s] forward to working with the new PAOC members to bring people with Medicare higher quality durable medical equipment items and services at lower prices."

CMS states that the PAOC will be comprised of 10 to 12 members, including consumer representatives, physicians, suppliers, professional standards organizations and financial standards specialists. The statement also noted that a pair of previous demonstration projects confirmed that competitive bidding does not hinder access or quality. Nominations are due Nov. 3.

Tuberculosis admissions down in '06

The Agency for Healthcare Research and Quality reports that hospital admissions for tuberculosis (TB) were down in 2006, but the disease is still a costly one.

According to the Healthcare Cost and Utilization Project report, dated October 2008, TB was described as the primary reason for a hospitalization a total of 8,800 times in 2006, which is down sharply from 1995, when roughly 15,000 were admitted with a primary diagnosis.

However, the bacteria involved, Mycobacterium tuberculosis, is still a large factor as a pathogen, showing up as a secondary diagnosis in almost 50,000 hospital stays in 2006, down from 55,500 in 1995.

According to AHRQ's numbers, hospital admissions related – primarily or otherwise – to TB ran up a tab of $752 million, and hospital stays for primary diagnoses of TB cost an average of more than $20,000, a testimonial to the persistent nature of the bacterium. True to form, the regional variance was conspicuous, with the Midwest accounting for an admission rate of 1.4 stays per 100,000 while the Northeast topped the list at 3.6 per 100,000. These are both statistics for primary diagnoses. The report did not include speculation as to whether high population densities are part of the reason that the numbers for the Northeast are so high.

Public health programs paid for almost half the primary diagnosis cases, with Medicaid paying 24.4% of all such hospital stays "even though Medicaid covers only 12.3% of non-maternal, non-neonatal stays," the report notes. Medicare handled another 22% of primary diagnosed cases. Private payers reimbursed almost 22% of these cases.

As for payment for secondary diagnoses of TB, Medicare handled more than 52% and Medicaid 19%. Private insurance handled less than 16%.

The primary diagnosis most likely to be associated with a secondary diagnosis of TB was, not surprisingly, pneumonia at a bit more than 10%, followed by chronic obstructive pulmonary disease at 7% of all cases. Acquired immune deficiency syndrome was third at 5.3%, while congestive heart failure accounted for 2.9% of all secondary diagnoses of TB.

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