This morning President Obama announced his plan for reforming healthcare. The proposal is similar to the legislation the Senate passed late last year, though it includes some concessions to the House, and the president describes it as "[bridging] the gap"... more
More than a week after Republican Scott Brown was elected to fill Ted Kennedy's seat in the Senate, healthcare reform remains stalled in Congress. Legislators have several options available to them to further the reform package, summarized below, though no... more
Scott Brown, a Republican state senator, won Edward Kennedy's Senate seat last night in Massachusetts. He defeated Democratic favorite Martha Coakley, who just a few weeks ago seemed a shoo-in for the seat. Brown won by a "decisive margin" with... more
National news today is focused on the Massachusetts election for Ted Kennedy's former Senate seat. The vote pits Republican Scott Brown against state Attorney General Martha Coakley, a Democrat. The New York Times recounts how Brown, a state senator, has... more
Legislation The Senate voted 60-39 last week to pass the chamber's healthcare reform legislation. Included in the legislation is a change to the timeline of the medical device tax: the tax will be implemented in 2011, later than the original... more
On Christmas Eve the Senate voted 60-39 to pass the chamber's healthcare reform legislation. The bill is expected to cost $871 billion over the next decade and promises to widen healthcare coverage by expanding Medicaid and implementing new regulations for... more
The Senate reversed a plan introduced last week to expand Medicare to allow patients to join at 55. If effected, the plan would have provided additional insurance options to patients who may have had difficulty obtaining coverage elsewhere, helping to... more
In the second week of debate, the Senate moved closer to finalizing its healthcare reform bill as the chamber scrapped its plans for a public insurance option. Instead, private payers would have the opportunity to participate in a low-cost plan... more
Last week the House voted 243-183 in favor of a new bill that would prevent a 21% cut to Medicare payments due to take effect in January, scrapping the SGR method that ties payments to economic growth and thus permanently... more
Yesterday the Senate introduced its version of healthcare reform legislation, which promises to provide insurance coverage to 94% of the Americans by 2019 and, at $848 billion, comes in below President Obama's cost ceiling of $900 billion. Devicemakers should note... more
The House passed its healthcare reform bill 220-215 this weekend after an unusual Saturday session. This rather narrow victory offers a prelude to what is sure to be a challenging vote in the Senate, as the same contentious issues are... more
Following in the footsteps of a Senate bill introduced two weeks ago, the House has now released its own legislation to permanently fix scheduled cuts to Medicare payments. Like the Senate's version, the House bill would scrap the SGR formula... more
Confirming a report from last week, the bill levies a 2.5% tax on medical devices at the point of sale. The House estimates that the tax will raise around $20 billion over ten years, approximately half the amount the Senate... more
Few details have been released from the House's healthcare overhaul legislation, but yesterday the Wall Street Journal reported that the House would offset reform costs by charging an excise tax on medical devices. The tax would be expected to raise... more
Sen. Debbie Stabenow (D-Mich.) introduced a bill last week that would block a 21% cut to physicians' Medicare pay. For the past several years, Congress has passed a one-year patch on scheduled pay cuts; the Stabenow bill would be a... more
A Senate Finance Committee panel voted 14-9 today in favor of healthcare reform legislation. Senator Olympia Snowe was the only Republican on the panel to support the bill, which will proceed to a chamber-wide floor debate later this month. While... more
The Wall Street Journal reported this morning that AdvaMed made a $15 billion counter-offer to reduce the impact of Sen. Max Baucus' healthcare reform bill on the device industry. The Senator reportedly said the offer was too low, and the... more
Last week the senators from Minnesota and Indiana, both states with thriving medical device industries, sent a letter to Max Baucus opposing the Senate Finance Committee's healthcare reform proposal. Echoing the sentiments of AdvaMed and others, the senators argue that... more
M&A Integra LifeSciences acquired the assets of Innovative Spinal Technologies, Inc. (IST) for $9.25 million in cash. Last year the company recorded $2.2 million in revenues, though they ceased operations in January and went into liquidation in May. This transaction... more
Today Senator Max Baucus formally introduced the Senate Finance Committee's long-awaited healthcare reform proposal, which would cost $856 billion and does not include a public option, would not require employers to purchase insurance for employees and would bar certain payer... more
A Senate healthcare reform plan introduced by Max Baucus over the weekend includes a $4 billion annual tax on the medical device industry to help offset the cost of healthcare reform. The tax would be implemented in 2010 and is... more
While President Obama missed his target of passing healthcare legislation this summer, reform is certainly moving ahead. A House bill overhauling the U.S. healthcare system will receive a floor vote after the August recess, progress that follows a 31-28 positive... more
Senate Majority Leader Harry Reid of Nevada confirmed last week that a vote on healthcare reform legislation would be delayed until after the chamber's August recess, a move that was generally anticipated but still effectively derails President Obama's promise to... more
Healthcare reform legislation appears no closer to a vote than it did a few weeks ago, with the Congressional Budget Office determining that the latest drafts of bills would do little to curb healthcare costs. CBO Director Douglas Elmendorf said... more
Representatives Bill Pascrell Jr. (D-NJ) and Lloyd Doggett (D-TX) introduced a bill in the House last week that would establish a U.S. joint registry. If the registry is established, the U.S. would follow Australia, England and Sweden in creating similar... more
President Obama addressed the American Medical Association in Chicago on Monday to gain support for healthcare reform, while in Washington, legislators weighed details of universal coverage as well as spending cuts and new taxes that would fund the $1 trillion... more
Last year's Riegel v. Medtronic Supreme Court case upheld preemption for medical devices, meaning FDA approval superseded any action that could be brought against a manufacturer in state court, effectively preventing product-liability lawsuits. That ruling is being challenged in the... more
President Obama is moving ahead with U.S. healthcare reform, and yesterday he provided an overview of part of his plan with a coalition of insurers, industry groups and physicians behind him. During the 1990s, President Clinton's push for a healthcare... more
House Democrats Henry Waxman and Frank Pallone announced plans to introduce a bill that would allow patients to sue medical device manufacturers over failed implants. Per last year's Reigel v. Medtronic ruling, FDA approval of a device preempts state tort... more
The new federal stimulus bill, signed into law last Tuesday by President Obama, includes a number of measures to shore up the healthcare sector against the contracting economy. The package's $787 billion in pledged assistance includes measures for states to... more
On a members-only webinar this week, the MDMA provided detailed information on the Physician Payment Sunshine Act, from its origins to the nuances of compliance to a timeline for implementation. The bill was first introduced in 2007 by Senators Grassley... more
Last week the House passed a child-health bill that would place severe restrictions on physician-owned hospitals. These hospitals are frequently criticized for cherry-picking patients, providing incentives for unnecessary tests or procedures and driving up costs at other centers, many of... more
According to a report by FDA News, Charles Grassley (R-Iowa) plans to reintroduce the Physician Payment Sunshine Act in the 111th Congress. The bill, first introduced in 2007, will require device makers to publicly disclose any payments or gifts given... more
When George W. Bush took office in 2001, one of his first executive orders was to restrict federal funding of stem cell research based on his belief that destroying embryos to obtain the cells was equivalent to destroying human life.... more
The morning after this historic election, President-Elect Barack Obama and an incoming Democratic Congress promise government-wide change and progress. How will the medical device industry be affected by the new administration? While details of the new administration's healthcare proposals are... more
The 510(k) clearance process as we know it - roughly 90 days of FDA review time and minimal data requirements - could become more burdensome in the next few years as the FDA responds to what's widely expected to be... more
Massachusetts governor Deval Patrick signed into law new regulations surrounding devicemakers' gifts to physicians. Per the new law, manufacturers must disclose in an annual report any gifts given in Massachusetts that are worth more than $50. According to FDA News,... more
The medical device industry has been closely following progress on the Physician Payment Sunshine Act (S. 2029), which is currently under review in Congress and intends to increase transparency in the relationship between physicians and manufactures. This bill was first... more
Last month, the Supreme Court ruled in Riegel v. Medtronic that FDA approval pre-empted product-liability lawsuits in state courts. The landmark decision was a vote of support for the FDA's authority, but it raised concerns about the implications for patient... more
Earnings Artimplant reported 4Q:07 revenues of SEK 5.0 million ($0.8 million), up from SEK 1.6 million ($0.25 million) in the year-ago period. The net loss for 4Q:07 was SEK 2.1 million ($0.34 million), improved from a loss of SEK 9.5... more
In the January 30th issue of the New York Times, healthcare reporter Reed Abelson takes a critical look at spine surgery, and in particular a novel device called Prodisc in an article titled "Financial Ties Are Cited as Issue in... more
Senators Charles Grassley (R-IA) and Arlen Specter (R-PA) are sponsoring a bill that would require manufacturers of implantable medical devices to provide quarterly data on the average and median selling prices for devices used in both inpatient and outpatient procedures.... more
Last week's Medical Device Manufacturers Association Annual Meeting in Washington, D.C. gave us an opportunity to applaud the passion and dedication that defined MDMA's past accomplishments and will carry future negotiations on regulatory, reimbusement and marketplace issues for smaller device... more
With a small market and conditions that are relatively rare, pediatrics hasn't drawn a lot of product development in the device space. As a result, children may receive devices that aren't appropriately sized for them or are lacking in data... more
A new bill was introduced in the New Jersey state legislature earlier this month that would allow patients to decide if they want to receive a reprocessed medical device. A similar bill was introduced in Massachusetts last year, but it... more
This afternoon MDMA held its monthly call, outlining policy changed that are on the horizon for 2007. We've outlined some of their comments below: MDUFMA Negotations for MDUFMA II have been ongoing since February of 2006. The FDA has recently... more
Asia's continued economic growth makes it an attractive market for both the sale and manufacture of medical devices. Pacific Bridge Medical, a medical consulting firm focusing on business development and regulatory affairs in Asia, recently published an article on the... more
February 2010 update: This report is no longer available for purchase. Learn more here. Fact: GPO-negotiated contacts drive more than $100 billion in device purchases by hospitals. News Item: The DOJ, the Connecticut Attorney General, three U.S. Senators, and the... more
This week CMS proposed a 5.1% reduction in payments to physicians for 2007. The proposal will impact the 875,000 doctors who care for the elderly and disabled in the US. The explanation for the cut is that spending on physician... more
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