A Medical Device Daily

The Centers for Medicare & Medicaid Services reported recently that it will cover the use of positron-emission tomography (PET) in the initial staging of most solid tumors. Previous coverage for such uses of PET fell under the coverage with evidence development (CED) rubric, which requires that reimbursement be tied to the conduct of a clinical trial designed to establish whether such treatment is reasonable and necessary.

CMS reopened the question to a national coverage analysis in January (Medical Device Daily, Jan. 8, 2009), but the coverage decision deals primarily with the initial use of PET to diagnose and stage the treatment of most of the cancers in question, a list that includes lymphomas and melanomas and cancers of the cervix, breast and ovary. However, CMS's decision also provides reimbursement for follow-up imaging for diagnoses of myeloma and for cervical and ovarian cancers.

Acting CMS administrator Charlene Frizzera said in the statement that the decision "shows that the CED program is a success," although the statement also notes that the decision "is the first time that CMS has reconsidered a coverage policy based on new evidence developed under the CED program."

The agency opted in 2005 to put PET on the CED list contingent on the submission of data to the National Oncological PET Registry (NOPR), operated jointly by the American College of Radiology (ACR; Reston, Virginia) and the ACR Imaging Network (ACRIN; Philadelphia). Among the other participants in the ACRIN effort are the Society for Nuclear Medicine (SNM; Reston, Virginia) and the American Society for Clinical Oncology (Alexandria, Virginia).

James Thrall, MD, chairman of the board at ACR, said in an April 6 statement that the NOPR "is a shining example of how the medical community can interact with government on research that can ultimately save and extend patients' lives." In an April 3 statement, Robert Atcher, PhD, President of SNM, described the move as "a major victory for patients" and said the coverage "demonstrates the intrinsic medical value of PET and the important role of these scans in diagnosing, staging, restaging and monitoring treatment for many cancers."

Bill would hand off tobacco to FDA

FDA is not known as an agency with too little on its plate, a consideration that undergirded conflicting proposals to regulate tobacco in the House Energy and Commerce Committee last week. The committee passed a bill, H.R. 1256, that would put oversight of tobacco in the agency's basket and would fund the effort with taxes on tobacco that are projected by the bill's backers to generate more than $5 billion in the first decade. However, increases in tobacco taxes have in the past often blunted consumption, thus leading to a lower tax take than projected.

The committee voted 39-13 to pass the Family Smoking Prevention and Tobacco Control Act of 2009 along to the full House, but Rep. Steve Buyer (R-Indiana) offered an alternative that would have forged a new agency at the Department of Health and Human Services to deal with tobacco. That proposal died by a vote of 33-17.

In an April 2 statement, committee chairman Henry Waxman (D-California) said, "I have every hope for firm and certain action by the Senate to pass this legislation so we can at long last send it to the President and better protect the American people from tobacco with the full force of our public health laws." The Senate last year declined to take up a similar measure passed by the House by a vote of 326-102, a tendency routinely decried by members of the House as obstructionism. On the other hand, the conventional thinking about the relationship between the two chambers has always been encoded in the adage that "the House is for offense and the Senate is for defense."

Palazzo case turns up heat on CIs

Clinical investigators (CIs) have been subject to FDA's regulations at least as far as the dreaded warning letter for years, and those warnings have at times been followed by disqualification from conducting clinical trials by means of a document known as the "Notice of Initiation of Disqualification Proceedings and Opportunity to Explain," or NIDPOE letter.

Punitive legal action beyond these letters, however, has been a gray area, partly because there is no law that makes specific demands on clinical investigators. FDA's enforcement authority has always been imputed by the law's requirements of sponsors, but recent case law seems to be trying to close that loophole – albeit unevenly – allowing prosecution of CIs who fail to hew to clinical trial requirements.

The case of U.S. v. Palazzo recently came to a close in the Fifth Circuit Court of Appeals, which ruled that a lower court erred in its determination that the law does not hold CIs criminally liable for failure to observe regulations. However, the Feb. 6 decision runs counter to at least one other case that found its way to U.S. appeals courts.

In 1984, the U.S. Ninth Court of Appeals found that the law did not hold CIs liable in the case of U.S. v. Smith, partly because the law was ambiguous, but U.S. Eighth Appeals ruled 10 years later that deference could be shown to FDA in the matter, hence allowing prosecution, even if the language of the law remained somewhat ambiguous. However, the decision in U.S. v. Garfinkel also determined that the law provided an "intelligible principle" that work inferentially toward FDA's authority.

The problem in the Palazzo case is that it seems to split the difference between Smith and Garfinkel. According to JP Ellison of Hymen Phelps and McNamara, a DC law firm, the Fifth Appeals Court simply looked at whether the law forbade omissions in clinical trial record-keeping and whether such omissions could be prosecuted as felonies. Ellison points out, however, in his entry at FDALawBlog.net, that this decision was made possible by the fact that the defendant conceded going in that the law gives the agency the authority to make such requirements of CIs.

Ellison does not explain the basis of the defense, but he does assert that this issue "may end up in the Supreme Court" before it is decided.

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