A Medical Device Daily

The congressional push to eliminate federal pre-emption of state liability law for medical devices got another boost last week with the introduction of a Senate companion bill to the Medical Device Safety Act of 2008, introduced earlier this year by Rep. Frank Pallone (D-New Jersey).

The Senate bill, titled the Medical Device Safety Act, was introduced by Senate Judiciary Committee chairman Pat Leahy (D-Vermont), who said in a statement that the relevant passage in the Medical Device Amendments of 1976 "is not, and never was, intended to preempt all common law claims of consumers injured by a federally approved medical device."

The bill is co-sponsored by 11 Senators, all Democrats, including Ted Kennedy (D-Massachusetts). Anthony Coley, a spokesman for Senator Kennedy said, "Senator Kennedy believes the Court's decision ignores both Congressional intent and 30 years of experience in which FDA regulation and tort liability have had complementary roles in protecting consumers from faulty medical devices.

Pallone, chairman of the House Energy and Commerce health subcommittee, formally unveiled his bill in late June (Medical Device Daily, June 30, 2008), and said in an accompanying statement that the Supreme Court decision in the case of Riegel v. Medtronic "gave medical device makers blanket immunity for the life of a product." However, industry's view is that neither the law nor the Supreme Court ruling applies to PMA devices that are demonstrated to be defective. Pre-emption for 510(k) devices was overturned in the 1990s in another case involving Medtronic (Minneapolis), Medtronic v. Lohr.

FDA publishes user fee schedule for '09

FDA published its device user fee schedule for fiscal 2009 in the Federal Register last week, but while many in the device industry complain that making devices is getting ever more expensive, it would appear that at least some of the increase in user fees is offset by general inflation.

Of course, some device makers are in a better position than others to pass along the consequences of inflationary pressures.

A PMA ran small businesses a bit more than $46,000 in the year ending Sept. 30, but that figure will rise to almost $50,200 the following day. This represents a jump of 9.2%, but the 5% rate of overall inflation over the past year seems to cut this number down a bit. The bar to qualify as a small business is still set at $100 million in annual revenues, making this at least the third consecutive year the agency has employed that threshold.

For their bigger brethren, a PMA will drain exactly $200,725 from the bank account, also a 9.2% jump from the previous fiscal year's sum of an even $185,000. Large firms will have to cough up almost $3,700 for 510(k)s, up from just a dash more than $3,400, and small companies will pay almost $1,850 rather than the approximate $1,700 they're paying in the current fiscal year.

Pennies may be pass , but the dollar bill surely is not. There are no fees listed in the FR notice that are an even number of hundreds of dollars, and only one fee actually ends in zero. For instance, a real-time PMA supplement costs large companies $14,051 whereas small companies have to write a check in the precise sum of $3,513.

Really "small" companies, those making less than $30 million, may be able to sidestep the fees altogether, but a company wishing to avail itself of this discount has to file for the exemption at least 60 days before filing any applications or reports for which it wants exemption from the fees.

Rehab facilities get zero update for '09

The Centers for Medicare & Medicaid Services announced the impending publication of its fiscal year 2009 fee schedule for inpatient rehabilitation facilities (IRFs) last week, which the agency said will be designed to "improve the accuracy of payment for services." The agency intends to post the final rule on Aug. 8.

The announcement also notes that CMS will recalculate "the weights assigned to the case-mix groups (CMGs) using more recent data from rehabilitation hospitals about the types of patients they are treating and the resources required," but CMS also noted that "as required by the Medicare, Medicaid, and SCHIP Extension Act of 2007 (MMSEA), the final rule sets the inflation update for the standard federal rate at zero percent for FY 2009."

The announcement affects more than 1,200 facilities, and CMS projects that Medicare payments to IRFs under this final rule will be about $5.6 billion in the coming fiscal year. Acting CMS administrator Kerry Weems said in a statement "the payment rates and policies adopted in this final rule will make it possible for beneficiaries who are severely impaired by illness or injury, but who are able to participate in an intensive program of rehabilitation, to obtain high quality care in an inpatient setting."