A Medical Device Daily

The Centers for Medicare & Medicaid Services has to cope with the impact of new technology on medical treatment, but sometimes some old-timer technologies resurface as reimbursement issues. This is the decidedly the case where proton beam therapy (PBT) is concerned, especially in connection with a proposal last year to examine the possibility of covering PBT treatment of prostate cancer. However, the situation is unresolved and the change of administration seems to offer little prospect of action anytime soon

One opponent of such an expansion of coverage is Mark Thompson, MD, of the Florida Radiation Oncology Group (Orange Park, Florida), who wrote in an Aug. 8, 2008, letter to CMS that "the results in treating prostate cancer are no better than using IMRT (intensity-modulated radiation therapy from an X-ray source) or prostate brachytherapy, which cost a fraction of proton therapy." Thompson made the case that until the data for PBT "support superior results ... protons for prostate cancer should not be funded."

Taking a different tack is Leonard Artz, executive director of the National Association for Proton Therapy (NAPT; Silver Spring, Maryland), who faxed to Medical Device Daily a copy of the Sept. 26, 2008, letter he sent to CMS on the matter. Artz wrote that "authoritative evidence does exist demonstrating that the benefits ... far outweigh any anticipated risks" thanks to the therapy's "greater precision" in terms of dosing area.

Artz's position is backed by a Sept. 25, 2008, letter to CMS from Ruthita Fike, CEO of Loma Linda University Medical Center (Loma Linda, California), which states that "PBT can be distinguished from IMRT based on both the volume of normal tissue treated ... and the amount of radiation exposure to normal tissue," adding that increased exposure from IMRT "can lead to a second malignancy or unwanted side effects to the normal tissue, which make take years, perhaps decades, to develop."

A third position was offered by the American Society for Radiation Oncology (ASTRO; Fairfax, Virginia), whose Sept. 25, 2008, letter, e-mailed to MDD, recommended "that the coverage with study participation policy be applied" to a "comparative registry study (possibly with a parallel randomized clinical trial arm)," which "is likely to provide meaningful answers" on the safety and efficacy of PBT in this use.

Neither ASTRO nor NAPT would comment for the record.

FDA guidance on enterovirus assays

FDA released a guidance on class II controls for assays that use nucleic acid amplification for detection of the enterovirus, ratcheting down the requirement for this class of diagnostic from a class III device. However, the guidance addresses only such tests when using samples from the patient's cerebrospinal fluid, and sponsors will have to conduct clinical trials in at least three sites that are "representative of where you intend to market the device."

According to the accompanying announcement in the Jan. 2 edition of the Federal Register, diagnostics maker Cepheid (Sunnyvale, California) "submitted a petition dated March 9, 2007," requesting the reclassification in reference to the company's Xpert EV system.

The guidance states that sponsors will still have to demonstrate that their assay "can detect all serotypes (currently 64 serotypes) that have been associated with aseptic meningitis," a list that includes coxsackievirus in addition to enterovirus. FDA states also that the guidance does not apply to assays testing for enterovirus in asymptomatic individuals, noting that such an intended use would require study designs that deal with a screening function.

With regard to reagents employed in an applicant's assay, the agency states that it is working on a "draft guidance regarding nucleic acid amplification testing, which will be particularly relevant when it is finalized." As for external controls, sponsors will have to employ them "every day of testing for the duration of the analytical and clinical studies."

In order to establish the precision of the assay, sponsors are expected to "test sources of variability (such as operators, days, assay runs) for a minimum of 12 days (not necessarily consecutive) with two operators each performing two runs per day and two replicates of each sample per run."

As for the trials, FDA recommends "prospective clinical studies" that may use archived samples from patients "from whom fresh specimens may not be readily available." The trial should be designed to generate a "90% sensitivity with a lower-bound of the two-sided 95% confidence interval greater than 80%." FDA is not opposed to outside-U.S. data as indicated by the statement "at least one of the study sites should be a U.S. site." Also, one of those sites "may be in-house."

Senate passes CHIP bill

The reauthorization for the Children's Health Insurance Plan (CHIP) moved closer to completion last week with a 66-32 vote in the Senate to pass a 4.5 year financing. The Senate bill would boost federal CHIP moneys by $32.8 billion over that term, an increase of about $6.5 billion per year over the current amount of $5 billion, and is expected to add 4 million to the 7 million already covered. Objections to the move cite the fact that many states use CHIP monies to pay for adults, including the widely cited fact that 87% of Minnesota's CHIP enrollees are adults.

The Senate bill pays for the expanded coverage by boosting the federal excise tax on cigarettes from 39 cents to $1 a pack, but some fear that the increase will blunt smoking, which may drop the amount of tobacco taxes collected.

The House passed its own CHIP bill Jan. 14 by a vote of 289-139 (Medical Device Daily, Jan. 29, 2009), which would also depend on tobacco taxes to offset the expected sum of $33 billion in additional spending over the 4.5 year period. The House bill also depends on an increase in tobacco taxes. One of the points of opposition to both bills is that they reduce the documentation requirement for immigrants who apply for CHIP care, a situation opponents say will foster illegal immigration.