A Medical Device Daily

The world's most populous nation is not the most heavily populated with regulations governing medical devices, but China's State Food and Drug Administration (SFDA) is closing the gap, or so says a March 4 report on the matter published by the DC law firm of Hogan & Hartson (H&H).

The report, titled "China Update: Pharmaceuticals & Medical Devices Special," states that SFDA "will establish a state medical devices standardization committee ... to uniformly administrate the existing 22 committees" that currently deal with medical device standardization and technology. The H&H report also states that SFDA has it in mind to "rebuild and expand the laboratories of nine national device testing institutions and update their testing equipment." China is said to currently operate 48 device testing operations, 10 of which are operated by SFDA. The agency is also expected to draw up as many as 10 guidelines to standardize medical device testing.

The report says that SFDA regulations for adverse event reporting went into force in December that require that device makers and their representatives in China "establish a monitoring and management system" to that end. The agency is expected to "accelerate the revising" of existing requirements for safety and efficacy. Regulations governing device recalls, the report states, are in draft form and may in final form require recalls if injuries result from design or manufacturing flaws or are expected to cause injury. Devices that violate laws and regulations will also be subject to recall, but the exact meaning of the word "recall" is unclear from the H&H report.

Finally, the report states that SFDA "plans to draw up the provisions" for clinical trial administration, which are expected to "definitely impose more stringent requirements." The report also notes that SFDA will most likely publish regulations dealing with device design, development and manufacturing, a set of regulations that are expected to employ standards under development by the Global Harmonization Task Force.

CBO: reform savings hard to snare

The Congressional Budget Office's new director, Douglas Elmendorf, testified on Capitol Hill last week about proposed reforms to healthcare, but his testimony might not have comforted proponents of reform as much as they'd hoped. CBO posted a copy of Elmendorf's March 10 report to the health subcommittee of the House Energy and Commerce Committee, and the news is that many of the anticipated savings will take a decade to materialize, assuming they ever will.

The report states, for instance, that savings from disease management plans "can improve health and may well be cost effective," but not if "the number of people receiving the services is generally much larger than the number who would avoid expensive treatment" with such services. The much-ballyhooed medical home, Elmendorf notes, "might have little impact on spending if the primary care physicians ... were not given financial incentives to economize their patients' use of services."

Regarding preventive health, the CBO chief states that services toward that end "could be cost reducing overall, but if the government began providing that service for free, federal costs would probably increase" if only because some of that care would have been provided in any event, but the cost of which would have been shared.

As for federal spending on healthcare information technology, the report states that the economic stimulus bill "will increase spending for the Medicare and Medicaid programs by about $30 billion" by 2019. Add in another billion for administrative costs and the savings of about $13 billion means that the stimulus bill will "increase direct spending on net by about $21 billion" by 2019.

The last sacred cow on Elmendorf's list, comparative effectiveness (CE), fares little better. He states that for CE studies to have any effect, they would "have to change the behaviors of doctors and patients," but payers would have to "incorporate the results in their coverage and payment policies" to see any benefit. This, Elmendorf notes, "would require legislative action" for Medicare and Medicaid, and though private payers have the option of doing so unilaterally, they nonetheless "might be reluctant to take such steps if Medicare did not do so."

Perhaps the most interesting statement regarding the systemic impact of the different arrangements between providers and payers started off by noting the difficulties inherent in the fee-for-service arrangement. However, Elmendorf cites a study that "randomly assigned enrollees to different health plans and found that those in an integrated plan ... used 30% fewer services than those enrolled in a fee-for-service plan."

CMS opens analysis for HIV screen

The Centers for Medicare & Medicaid Services reported last week that it will undertake a national coverage analysis for screening for the human immunodeficiency virus (HIV).

According to the March 13 announcement, the idea originated at CMS based on a set of guidelines published by the United States Preventive Services Task Force, which CMS says has strongly recommended" such screening. The notice states that CMS is "especially interested as to the types of studies needed if the evidence is determined to be premature for coverage or if the appropriate frequency interval [for testing] is uncertain."

CMS states that the public comment period will run until April 12 and that the agency will publish a proposed decision memo by Sept. 13. The process should be wrapped up by Dec. 12, CMS says, if all goes according to plan.

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