Medical Device Daily Washington Editor
Trade negotiations between the U.S. and China have been pockmarked with conflict, but the recently concluded round of negotiations have worked out well for the device industry, even if U.S. automakers aren't so happy.
In an Oct. 30 statement, the Advanced Medical Technology Association (AdvaMed; Washington) welcomed "a series of commitments aimed at streamlining the regulatory process for medical devices" announced by mainland China during negotiations conducted as part of the U.S.-China Joint Commission on Commerce and Trade.
The AdvaMed statement notes that Beijing has promised to drop the requirement that companies shipping devices to China "register their products in the country of export as a condition of registration in China." Beijing is said to have agreed to accept a product registration document issued by any nation "regardless of its exporting origin, country of manufacture or legal manufacture."
Beijing is said to have also committed to consider clinical trials conducted in other nations as evidence toward device approvals, but will employ a risk-based approach in deciding which products can be approved via foreign-nation trials.
Ralph Ives, executive VP for global strategy and analysis at AdvaMed, said in the statement that the association "applauds China for committing to measures we believe will streamline the medical device regulatory process and provide the Chinese people with access to the most innovative and advanced medical technologies in a timely manner."
Trade relations between the world's most populous nation and the world's largest economy have been noisy at times. Issues regarding automobile imports are said to serve as quite the sticking point lately, even given the conflicts over steel and pirated music and movies. Adding to the heat in current relations was the announcement in September by the Obama administration that it would impose a duty of 35% on auto tires made in China.
DME supplier pleads guilty to fraud
The Department of Justice reported recently that the owner of a durable medical equipment supply company in the Houston area has taken a guilty plea on charges of fraud.
According to a Nov. 2 DoJ statement, Noel Jhagroo entered a guilty plea on charges that his company, Trucare Medical Equipment Services, billed the Centers for Medicare & Medicaid Services for equipment and supplies that were more often than not either medically unnecessary or not actually provided to beneficiaries.
Jhagroo's run began in April 2004 and continued through this past July, during which time he submitted roughly $962,000 in fraudulent claims. DoJ alleged that he typically billed Medicare for enteral nutrition products ordinarily provided only to patients on feeding tubes, even though only one patient for whom Jhagroo submitted such claims had a tube. Other fraudulently billed items included arthritis kits consisting of leg braces and heating pads. He will be sentenced on Feb. 23, 2010.
CBO scores House bill's subsidies
The Congressional Budget Office has scored the effects of subsidies that would be provided to enrollees in the health insurance exchanges described in H.R. 3962, the Affordable Health Care for America Act.
According to CBO, premiums for those enrolling in the basic plan under the bill in the year 2016 – described as the "reference plan" in the CBO analysis – "would vary by geographic area," but that subsidies would cover roughly 70% of total costs for covered services. The reference plan is assumed to cost a single person "about $5,300," which comes to a subsidy of roughly $3,710. The beneficiary would be responsible for the remaining $1,590 each year. The range for potential subscribers listed in the CBO document includes those at 100% of the federal poverty level (FPL), but H.R. 3962 also calls for Medicaid eligibility to be expanded to 150% of FPL.
CBO's memo states that the maximum amount of income that enrollees would have to pay toward healthcare costs in 2013 "would range from 1.5% for those with income less than or equal to 133%" of the FPL to 12% for those with income equal to 400% of the FPL. CBO notes that the share of premiums paid by enrollees would remain flat over time thanks to indexing.
Compared to the bill written by the Senate Finance Committee, the House bill would "tend to attract a less healthy mix of enrollees" due to greater subsidies, making this bill "more valuable to people with health problems" than those who are healthy, CBO states. The House bill also "restricts more sharply the extent to which premiums can vary by age," making the plans less attractive to younger, healthier enrollees and more attractive to older, less healthy enrollees.
The Republican Party finally published a draft healthcare reform proposal earlier this week, although details are sketchy going into the end of the week as the House begins debate on H.R. 3962.
According to wire service reports, the GOP plan runs to a svelte 230 pages compared to the 1,990 pages devoured by H.R. 3962, and does not include a mandate for businesses to provide insurance to employees. The bill also includes no individual enrollment mandate and is said to omit a provision to outlaw exclusion of coverage based on pre-existing conditions. The GOP plan would allow plans to operate across state lines and would cap non-economic damage awards in malpractice suits to $250,000.
House majority whip Steny Hoyer (D-Maryland) indicated that he believes that Republicans are too late to the party. He is quoted as saying that he is "confident of prevailing and ... confident of prevailing before Veterans Day." Veterans Day falls on Nov. 11 each year, which is next Wednesday.
Mark McCarty, 703-268-5690