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Orthopedic and Dental Industry News Complete Archive »


Research Shows that A Permanent Repeal of the Medical Device Tax Could Recover 28,000 Jobs for the Industry BY ANDREW VAHRADIAN, MARCH 3, 2017

The American Action Forum (AAF) estimates that the medtech industry could recover the 28,000 jobs that were terminated during the implementation of the the Affordable Care Act's 2.3% medical device excise tax by 2021 if Congress permanently repeals the tax... more

New Legislation Aimed at Streamlining Novel Medical Device Access to CMS beneficiaries Introduced to the U.S. Senate BY ANDREW VAHRADIAN, JUNE 2, 2016

Senator Dan Coats (R-IN) introduced legislation to expedite the transitional coverage and payment of innovative medical device technologies by the Centers for Medicare and Medicaid Services (CMS) to the U.S. Senate. The new bill, titled “Ensuring Patient Access to Critical... more

Senate Advances a Number of New Bills Aimed at Enhancing the FDA's Medical Device Regulatory Process BY ANDREW VAHRADIAN, MARCH 29, 2016

U.S. Senators, Amy Klobuchar (D-MN) and Pat Roberts (R-KS), have introduced a new bill to help streamline the FDA's methodology of reviewing medical devices to the Senate's Health, Education, Labor & Pensions committee. The new bill titled, “A bill to... more

Congress and White House Pass Legislation to Suspend 2.3% Medical Device Tax for Two Years BY ANDREW VAHRADIAN, DECEMBER 21, 2015

The House of Representatives and the Senate have both passed the Omnibus Appropriations Act, a $1.1 trillion funding bill that will negate another government "shut down" and keep the U.S. federal government functioning until September 30, 2016. Within this legislation... more

New Government Spending Bill Provides Provision to Rescind 2.3% Medical Device Tax for Two Years BY ANDREW VAHRADIAN, DECEMBER 16, 2015

Last evening Congress struck a $1.1 trillion spending deal that is necessary to avoid another "shut down" and keep the U.S. government functioning. Within this legislation, there is a provision that suspends the Affordable Care Act's 2.3% medical device excise... more

The U.S. House of Representatives Passes Clinical Trials Compensation Bill BY ANDREW VAHRADIAN, OCTOBER 20, 2015

The U.S. House of Representatives approved new legislation that would compensate patients that take part in clinical studies of rare diseases or conditions. The bill, called "Ensuring Access to Clinical Trials Act of 2015", would allow patients with rare diseases... more

Stephen Ubl to Step Down from AdvaMed to Join PhRMA BY ANDREW VAHRADIAN, OCTOBER 7, 2015

Stephen Ubl, the current President & CEO of the Advanced Medical Technology Association (AdvaMed), the leading lobbyist/trade group for the medical device industry, will step down from his post at AdvaMed (effective October 15th) to join the Pharmaceutical Research &... more

Senate Approves the Protecting Access to Medicare Act of 2014 BY ANDREW VAHRADIAN, MARCH 31, 2014

The Senate approved the Protecting Access to Medicare Act of 2014, more commonly referred to as a "doc fix" bill, by a vote of 64 to 35. The bill suspends Medicare's sustainable growth rate (SGR) formula which would have cut... more

Advancement in Negotiations Regarding a Repeal of the Medical Device Tax BY ANDREW VAHRADIAN, OCTOBER 10, 2013

In recent weeks, House Republicans have made the repeal of the 2.3% medical device excise tax a prime focus in their larger opposition towards President Barack Obama's Affordable Care Act (ACA). They are seeking repeal or at least a delay... more

Growth of the Consumer Medical Device Marketplace Expected to Increase BY ANDREW VAHRADIAN, OCTOBER 3, 2013

A new report from IHS Inc. determined that as the "baby boomers" generation ages and the health care industry evolves into a system that emphasizes wellness and prevention, the global market for consumer medical devices will grow to more than... more

Taiwan Legislature to Ratify Additional Tax Reductions and Subsidies for Medical Device Manufacturers BY ANDREW VAHRADIAN, SEPTEMBER 4, 2013

The Taiwanese legislature is likely to ratify a draft bill in the upcoming session allowing manufacturers of high-risk medical devices to receive tax reductions and government subsidies. There is currently a consensus among legislators for such an initiative and if... more

Further Development on Medtech Tax Repeal BY ANDREW VAHRADIAN, AUGUST 6, 2013

The Protect Medical Innovation Act of 2013, co-sponsored by House Representatives Erik Paulsen (R-MN) and Ron Kind (D-WI), has accumulated 259 signatures in the 435-seat U.S. House of Representatives, according to the Library of Congress' THOMAS database. The Bi-partisan bill,... more

Hospitals to Settle with Federal Government over Fraudulent Billing Scheme BY ANDREW VAHRADIAN, JULY 9, 2013

Fifty-five hospitals in 21 states will be paying a total of $34 million to the federal government in order to settle allegations that they overcharged Medicare and other government healthcare programs for kyphoplasty back procedures. The settlements were the result... more

Progress on Medtech Tax Repeal BY ANDREW VAHRADIAN, APRIL 12, 2013

House Representative Erik Paulsen (R-MN) issued a statement regarding his Protect Medical Innovation Act seeking to repeal the Affordable Care Act's 2.3% medical device excise tax, has gained its 218th cosponsor in the House, giving the bill enough support to... more

The USPTO Takes Major Step Towards Harmonizing U.S. Patent Law with Foreign Patent Procedures BY ANDREW VAHRADIAN, MARCH 28, 2013

With the final implementation of the "first-inventor-to-file" provision of the Leahy-Smith America Invents Act (AIA) ratified on March 16, 2013, the United States Patent and Trademark Office (USPTO) has taken a major step towards revising the U.S. patent process and... more

Senate Votes in Favor of Repealing 2.3% Medical Device Excise Tax BY ANDREW VAHRADIAN, MARCH 22, 2013

Legislation seeking to repeal the Affordable Care Act's 2.3% medical device excise tax received overwhelming support late last night in Congress. The Senate voted 79-20 in favor of revoking the 2.3% excise tax on medical device companies' device sales. Thirty-three... more

Congressman Dan Maffei Introduces New Legislation Repealing the 2.3% Medical Device Excise Tax BY ANDREW VAHRADIAN, MARCH 22, 2013

House Representative Dan Maffei (D-NY) introduced new legislation to Congress seeking to retract the Affordable Care Act's 2.3% medical device excise tax in its entirety. Congressman Maffei’s proposed bill named, “The Medical Device Tax Elimination Act”, completely repeals the excise... more

CMS Publishes Final Sunshine Act Rule BY ANDREW VAHRADIAN, FEBRUARY 8, 2013

The Centers for Medicare and Medicaid Services (CMS) announced the long-awaited Final Rule of the Physician Payments Sunshine Act (Sunshine Act), which will raise public awareness of the financial relationships between medical device and pharmaceutical companies and doctors and teaching... more

Off-label Drug Promotion Upheld by Federal Court BY ANDREW VAHRADIAN, DECEMBER 7, 2012

A U.S. Court of Appeals has ruled that the FDA's ban on the off-label promotion of drugs between physicians and medical sales representatives violates a person's First Amendment right to free speech. The three-judge panel came to a 2-1 majority... more

Government Program Would Invite Patients to Report Medical Errors BY LAUREN UZDIENSKI, SEPTEMBER 25, 2012

Adverse events are typically reported by medical professionals via the FDA's MedWatch system, but a new initiative from the Agency for Healthcare Research and Quality (AHRQ) aims to encourage patients and consumers to submit "medical mistakes and unsafe practices" by physicians, hospitals and pharmacists. The New York Times reports that the government worries that many safety incidents are under-reported, and the consumer data could improve delivery of care and reduce adverse events, like infections, injuries or deaths. more

Are Federal Budget Cuts Jeopardizing FDA User Fees? BY LAUREN UZDIENSKI, SEPTEMBER 11, 2012

Bloomberg reported yesterday that the user fee agreement, which the FDA and industry finalized in February after months of negotiations, may now be in jeopardy due to Congressional budget squabbles. The FDA cannot use any of fiscal 2013's roughly $100... more

CBO: Supreme Court Ruling to Lower Costs of Health Reform While Expanding Coverage BY LAUREN UZDIENSKI, JULY 31, 2012

Last month, the Supreme Court largely upheld healthcare reform legislation, striking only one relatively small provision regarding state funding of the Medicaid program. Medicaid expansion was one way that President Obama's healthcare reform legislation was expected to insure 30 million of the 50 million uninsured lives in the U.S., but the Court ruled that states could opt out of this program, raising questions about how this would affect projections for newly-insured patients. more

Breaking: Supreme Court Upholds Healthcare Reform BY LAUREN UZDIENSKI, JUNE 28, 2012

The Supreme Court today upheld healthcare reform, ruling that the individual mandate was effectively a tax and as thus was constitutional. The individual mandate was considered one of the critical issues of the constitutionality of President Obama's legislation. One more minor provision was struck, having to do with state Medicaid funding, though most of the legislation will stand. more

Musculoskeletal News Roundup 28-Jun-12 BY LAUREN UZDIENSKI, JUNE 28, 2012

Benvenue raises $25M ... ZMH launches TM Ardis Interbody System for the lumbar spine ... Cartiva completes enrollment for their MOTION trial ... Corin expands LARS distribution agreement ... IART debuts private label version of the aap Implantate stainless headed compression screw system more

Device Tax Repeal Expected to Stall in Senate BY LAUREN UZDIENSKI, JUNE 11, 2012

The House voted to pass device tax repeal legislation last week, but companion legislation is not expected to pass the Senate, and President Obama has threatened a veto if the bill reaches his desk. more

House to Vote on Device Tax Repeal BY LAUREN UZDIENSKI, JUNE 4, 2012

Last week the House Ways & Means Committee voted 23-11 to repeal the 2.3% medical device tax, set to go into effect January 1. Now that the legislation has passed committee, the bill will go to the House floor for a vote. The Protect Medical Innovation Act, introduced by Minnesota rep Erik Paulsen, may reach a vote as early as this week. more

Musculoskeletal News Roundup 31-May-12 BY LAUREN UZDIENSKI, MAY 31, 2012

Globus Medical files amended S-1 ... Medtronic receives CE mark for SHILLA scoliosis system ... Zimmer launches Sidus Stem-Free Shoulder and TM Ardis Interbody System ... House and Senate pass user fee legislation ... Orthofix's Phoenix MIS and Firebird Pedicle Screw Systems to be integrated with Brainlab navigation systems ... TransCorp Spine names President and CEO more

User Fee Legislation Making Its Way through Congress BY LAUREN UZDIENSKI, MAY 9, 2012

Yesterday a House subcommittee unanimously voted to pass the user fee re-authorization for FY2013. The full Energy and Commerce Committee will mark up the bill on Thursday, with the intention of moving the bill to the floor quickly and passing it before the Supreme Court rules on healthcare reform in June. In the Senate, the Health, Education, Labor and Pensions Committee has approved the bill, and the legislation is expected to reach a floor vote next week. more

Awaiting the Supreme Court's Ruling on Healthcare Reform BY LAUREN UZDIENSKI, APRIL 2, 2012

Though we're not likely to hear the fate of healthcare reform until late June, the Supreme Court has likely already made their decision. As the Washington Post reports, the Court tends to decide quickly on cases, though it may take months for the Justices' decisions to be written and made public (as is expected to be the case with healthcare reform). In the meantime, there will be no public comment from the Court, leaving the media, public, industry and government officials to speculate on potential outcomes. more

Arguments Begin Today in Supreme Court's Health Reform Case BY LAUREN UZDIENSKI, MARCH 26, 2012

Arguments in the Supreme Court case reviewing the constitutionality of healthcare reform kick off today in Washington, D.C. The nation's highest court will be considering whether Congress has the authority to require individuals to purchase health insurance, among other issues, in a series of hearings that could derail President Obama's healthcare reform legislation and shake up an election year. more

JOBS Act to Lower Funding Hurdles for Small Businesses BY LAUREN UZDIENSKI, MARCH 14, 2012

New, bipartisan legislation passed in the House last week and working its way through the Senate now is designed to decrease the obstacles for small businesses raising funding, though critics argue that the new provisions may offer investors too little protection and may promote fraud. more

Congress Passes Doc Fix BY LAUREN UZDIENSKI, DECEMBER 27, 2011

On Friday, Congress passed a bill that would delay a scheduled 27% cut in CMS reimbursement rates. These cuts have been mounting for years, as Congress has postpone each annual pay reduction with a legislative patch known as the "doc fix." more

Congress Goes Back to the Drawing Board on CMS Pay Cuts BY LAUREN UZDIENSKI, NOVEMBER 23, 2011

On Monday the Congressional supercommittee dedicated to deficit reduction announced that their latest efforts have failed, and they would not reach an agreement by their Wednesday deadline. The committee convened to find an alternative to $1.2 trillion in budget cuts mandated by the 2013 federal budget, much of which would come from the Pentagon. However, these cuts include a scheduled 2% decrease to Medicare physician pay every year from 2013 to 2021. more

Device Tax Repeal Gaining Momentum as Affordable Care Act Inches Closer to Supreme Court BY SANDER DUNCAN, NOVEMBER 11, 2011

A movement to repeal the medical device tax is gaining momentum in Congress, even as the Affordable Care Act as a whole is upheld by a federal appeals court in Washington DC. The landmark healthcare legislation is slated to include a 2.3% tax on medical device company revenues, but a bill opposing this tax now has the minimum number of votes to pass in the House. more

President Obama Signs Patent Overhaul into Law BY LAUREN UZDIENSKI, SEPTEMBER 23, 2011

On September 16th, President Obama signed off on the most substantial U.S. patent overhaul since the 1950s. Most importantly, the America Invents Act will change the intellectual property infrastructure from a first-to-invent to a first-to-file system, a move that may favor large companies. more

Industry Urges Repeal of Device Tax BY LAUREN UZDIENSKI, JULY 19, 2011

Over 400 companies and trade associations, including MDMA, the U.S. Chamber of Commerce and a number of musculoskeletal companies, made up a coalition urging Congress to repeal the $20 billion medical device tax. Dated July 18th, the letter states that the tax will "adversely impact patient care and innovation, and will substantially increase the costs of health care." more

Rep. Erik Paulsen Launches Website for the Medical Technology Caucus BY LAUREN UZDIENSKI, MARCH 29, 2011

Rep. Erik Paulsen has launched a new website for the Medical Technology Caucus, a 48-member, bipartisan body that works to promote awareness among Congress members and staff of the role medical technology plays for both patients and the economy. more

Healthcare Reform At One Year BY LAUREN UZDIENSKI, MARCH 22, 2011

This week last year the monumental Affordable Care Act was signed into law, and even as the legislation's more moderate reforms go into effect, controversy still swirls over the law's constitutionality and budget impact. more

Senate Moves to Open Medicare Claims Database BY LAUREN UZDIENSKI, MARCH 8, 2011

The Medicare claims database has been closed since 1979, when the Florida Medical Association and the American Medical Association persuaded a court to keep doctors' pay private. Now two Senators, Charles Grassley and Democrat Ron Wyden of Oregon, are working on legislation that would allow the public access to the database, which contains records of physician claims and reimbursement amounts. more

Senate Rejects Healthcare Reform Repeal BY LAUREN UZDIENSKI, FEBRUARY 3, 2011

As predicted, the Senate voted 51-47 against repealing healthcare reform. The bill passed the House last month, but after Senate leaders initially refused to bring the legislation to the floor, the repeal act was tacked onto an aviation bill. more

Musculoskeletal News Roundup 3-Feb-11 BY LAUREN UZDIENSKI, FEBRUARY 3, 2011

CNMD, KNSY, RTIX report 4Q . . . Spine Wave raises $17.5M . . . Vertiflex raises $14M . . . Tornier goes public . . . BioMimetic Therapeutics gets FDA panel hearing date . . . ConforMIS knee system cleared . . . Healthcare reform found unconstitutional in Florida . . . Wright Medical expands supply agreement for GraftJacket . . . Biomet makes a donation to OREF more

Bill to Repeal Device Tax Introduced in the House BY LAUREN UZDIENSKI, JANUARY 26, 2011

Rep. Erik Paulsen introduced the Protect Medical Innovation Act this week, which would repeal the $20 billion device tax that was passed in last year's healthcare reform package. more

Federal Judge Rules Healthcare Reform Provision Unconstitutional BY LAUREN UZDIENSKI, DECEMBER 13, 2010

One of the most contentious provisions in President Obama's healthcare reform package - the individual mandate, which requires all Americans to purchase health insurance - has been declared unconstitutional by a federal judge in Virginia. more

Senate Reaches "Tentative" Deal for One-Year Doc Fix BY LAUREN UZDIENSKI, DECEMBER 7, 2010

Politico reports that Senate leaders have reached a "tentative" agreement for a one-year patch on the 23% cuts to Medicare reimbursement that are scheduled to go into effect on January 1. The deal would require a change to the healthcare reform plan's tax subsidy program, which will be implemented after 2014. more

Senate Passes One-Month Doc Fix BY LAUREN UZDIENSKI, NOVEMBER 22, 2010

The looming 23% cut to Medicare reimbursement was delayed by the Senate last week - for one month. more

Dental News Roundup September 2010 BY LAUREN UZDIENSKI, SEPTEMBER 30, 2010

Straumann launches new CAD/CAM portfolio . . . VITA expands shade range . . . EPA may require dentists to recycle mercury waste . . . BIOLASE increases sales force . . . Zimmer Dental to distribute RTI biologics worldwide . . . Sirona announces management changes more

NEJM Article Proposes Changes to Disclosing Academic-Industry Relationships BY SANDER DUNCAN, AUGUST 23, 2010

Studies show that a majority of academic researchers have affiliations with companies in their industry, yet the disclosures of these relationships to an academic's institution may be incomplete or inconsistent. An editorial published recently in the New England Journal of... more

Bolstered by Healthcare Reform, Medicare Fund to Last Until 2029 BY LAUREN UZDIENSKI, AUGUST 11, 2010

Medicare's Board of Trustees released its annual report last week, noting that the Medicare fund, previously expected to run out in 2017, will last until 2029 under the new healthcare reform legislation. more

Sen. Franken, AdvaMed Lobby Congress for Pediatric Device Incentives BY LAUREN UZDIENSKI, JULY 27, 2010

Sen. Al Franken and AdvaMed faced Congress last week, urging legislators to increase financial incentives for devicemakers addressing pediatric patient populations. more

California Congressman Introduces New Challenge for Device Tax BY LAUREN UZDIENSKI, JULY 6, 2010

Citing the damaging impact the device tax may have on jobs, Congressman Brian Bilbray (R-CA) introduced the Medical Device Tax Repeal Bill, or H.R. 5615. more

Musculoskeletal News Roundup 24-Jun-10 BY LAUREN UZDIENSKI, JUNE 24, 2010

Baxano closes $30M series C . . . SpineForm, Lanx, OrthoHelix receive $1M Ohio Third Frontier Commission awards . . . Aesculap launches S4 MIS Cannulated Pedicle Screw Spine Fusion System . . . Medtronic launches KYPHON ActivOs 10 Bone Cement with Hydroxyapatite . . . SNN granted injunction against Arthrex . . . Senate passes Medicare pay patch . . . Kensey Nash, Arthrex sign agreement over KNSY's ECM . . . Therapure, ProChon Biotech ink manufacturing deal . . . NuVasive leases NJ office space . . . BioTime creates new stem cell subsidiary more

Senate Rejects Doc Fix Legislation BY LAUREN UZDIENSKI, JUNE 17, 2010

Legislation that included a wide range of economic benefits, including an 18-month patch on a 21% cut to physician Medicare pay, was effectively rejected by the Senate yesterday. With a 52-45 procedural vote, the bill lacked the support of even a simple majority and missed the 60 votes the legislation would need to withstand a Republican filibuster. more

Another Deadline Passes for Doc Fix BY LAUREN UZDIENSKI, JUNE 4, 2010

Congress was due to act on the looming 21% cut to physician Medicare pay by June 1, when the prior patch expired, but the ongoing Memorial Day recess means legislators won't vote on a bill until at least Monday, June 7th. CMS says they won't process payments for 10 business days, giving the Senate a chance to reconvene and vote on another patch. Rinse, repeat. more

MA Law Would Require Physicians to Participate in Government Health Programs BY LAUREN UZDIENSKI, MAY 19, 2010

785px-Doctors_stethoscope_1.jpgA new bill proposed by the Massachusetts state legislature would force physicians to participate in Medicare, Medicaid and state health programs as a condition of licensure. The law would set physician pay at 110% of the Medicare reimbursement rate, which could pose financial hurdles for physicians in private practice. more

Health Reform Costs to Top $1 Trillion on "Discretionary" Spend BY LAUREN UZDIENSKI, MAY 13, 2010

USCurrency_Federal_Reserve_SMALL.jpgPresident Obama was adamant in the weeks leading up to the healthcare reform vote that costs would not exceed $1 trillion over a decade. The package passed at a projected spend of $940 billion, but now the CBO is expecting the overhaul to cost at least another $115 billion. The additional costs reflect administrative expenses and other "discretionary" funding measures to be approved by Congress at future dates. more

Minnesota Congressman Introduces Legislation to Repeal the Medical Device Tax BY LAUREN UZDIENSKI, APRIL 26, 2010

Erik_Paulsen_small.jpgLast week, Minnesota Congressman Erik Paulsen introduced a bill that would immediately repeal the 2.3% excise tax on the medical device industry levied in healthcare reform legislation. The Defend Medical Innovation Act has 26 co-sponsors, according to a press release on Paulsen's website. The Congressman argues that the tax will "harm job growth, slow innovation and raise costs." more

Healthcare Reform Passes in the House BY LAUREN UZDIENSKI, MARCH 22, 2010

800px-U.s._capitol.jpgThe House passed a healthcare reform package last night by a small margin, and now the final vote is in the Senate's hands. The House first passed the Senate's version of the bill from last year and then proceeded to pass a reconciliation bill consisting of revisions to the Senate's version. These changes included a last-minute adjustment to the medical device industry tax, which is now set at 2.3% annually. more

House Looks Ahead to a Healthcare Vote BY LAUREN UZDIENSKI, MARCH 16, 2010

Stethoscope_small.pngCongress appears to be moving closer to a vote on healthcare reform. While no vote is scheduled, Speaker Pelosi believes she has the support of House legislators as well as the mechanics in place to pass the legislation. The method by which the Senate's version of the bill will become law will not require a House vote, a process known as "deeming" a bill. more

Device Industry Seeks Cap on Healthcare Reform Fees BY LAUREN UZDIENSKI, MARCH 10, 2010

capitolbuilding_small.jpgWith healthcare reform projected to cost $950 billion, the pharma, device and hospital industries have generally consented to help fund the changes - in the device industry's case, to the tune of $20 billion over the next decade, which will be realized through an excise tax proposed to be implemented in 2011. AdvaMed is pushing on behalf of the industry to lock in that $20 billion as a cap, reports Reuters. more

President Obama Unveils Plan for Healthcare Reform BY LAUREN UZDIENSKI, FEBRUARY 22, 2010

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

What's in Store for Healthcare Reform? BY LAUREN UZDIENSKI, JANUARY 27, 2010

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

Healthcare Reform's Fate Uncertain as Massachusetts Elects Brown BY LAUREN UZDIENSKI, JANUARY 20, 2010

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

Healthcare Reform in Jeopardy as Massachusetts Goes to the Polls BY LAUREN UZDIENSKI, JANUARY 19, 2010

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

Musculoskeletal News Roundup 31-Dec-09 BY LAUREN UZDIENSKI, DECEMBER 31, 2009

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

Senate Passes Healthcare Reform, with Modifications to the Device Tax BY LAUREN UZDIENSKI, DECEMBER 28, 2009

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

Senate Drops Plan to Expand Medicare; Medical Device Tax Delayed Until 2013 BY LAUREN UZDIENSKI, DECEMBER 15, 2009

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

As Senate Abandons Public Option, Healthcare Legislation Moves Closer to a Vote BY LAUREN UZDIENSKI, DECEMBER 10, 2009

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

House Passes Physician Pay Fix BY LAUREN UZDIENSKI, NOVEMBER 23, 2009

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

Senate Introduces Healthcare Legislation with Lower Fees for Devicemakers BY LAUREN UZDIENSKI, NOVEMBER 19, 2009

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

House Passes Healthcare Reform Bill BY LAUREN UZDIENSKI, NOVEMBER 9, 2009

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

House Introduces Bill to Block Medicare Pay Cuts BY LAUREN UZDIENSKI, NOVEMBER 4, 2009

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

House Proposes Healthcare Reform Legislation; Device Fees Set at $20B BY LAUREN UZDIENSKI, NOVEMBER 2, 2009

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

House Healthcare Reform Bill to Include Device Tax; Senate Rumored to Lower Fees BY LAUREN UZDIENSKI, OCTOBER 27, 2009

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

Senate Bill would Block Medicare Pay Cuts to Doctors BY LAUREN UZDIENSKI, OCTOBER 19, 2009

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

Senate Finance Committee Panel Votes in Favor of Baucus Plan BY LAUREN UZDIENSKI, OCTOBER 13, 2009

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

Device Fee Negotiations Continue as AdvaMed Counter-offers BY LAUREN UZDIENSKI, OCTOBER 5, 2009

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

Senators React to the Medical Device Tax BY LAUREN UZDIENSKI, SEPTEMBER 22, 2009

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

Musculoskeletal News Roundup 17-Sept-09 BY LAUREN UZDIENSKI, SEPTEMBER 17, 2009

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

Senate Introduces Healthcare Reform Plan, Including Fees for Devicemakers BY LAUREN UZDIENSKI, SEPTEMBER 16, 2009

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

New Reform Proposal Calls for Savings from Devicemakers BY LAUREN UZDIENSKI, SEPTEMBER 9, 2009

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

House Committee Approves Healthcare Reform Bill BY LAUREN UZDIENSKI, AUGUST 3, 2009

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

Healthcare Reform Gains Momentum Ahead of August Recess, with Device Sector Impact Still Uncertain BY LAUREN UZDIENSKI, JULY 30, 2009

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

With an August Deadline Looming, Legislators Struggle with the Cost of Healthcare Reform BY LAUREN UZDIENSKI, JULY 20, 2009

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

House Proposes Artificial Joint Registry BY LAUREN UZDIENSKI, JUNE 22, 2009

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 Pushes Healthcare Reform, Though Lawmakers Question the Cost BY LAUREN UZDIENSKI, JUNE 17, 2009

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

Preemption at Issue in Medical Device Safety Act of 2009 BY LAUREN UZDIENSKI, MAY 20, 2009

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

Payers, Trade Groups and Physicians Pledge to Curb Growth of Healthcare Costs BY LAUREN UZDIENSKI, MAY 12, 2009

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

New House Legislation Would Allow Patients to Sue Devicemakers BY LAUREN UZDIENSKI, FEBRUARY 23, 2009

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

Stimulus Bill Includes Measures for Health IT, Comparative Effectiveness BY LAUREN UZDIENSKI, FEBRUARY 23, 2009

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

MDMA Offers Insight into the Physician Payment Sunshine Act BY LAUREN UZDIENSKI, FEBRUARY 12, 2009

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

New Legislation Could Hurt Physician-Owned Hospitals BY LAUREN UZDIENSKI, JANUARY 22, 2009

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

Congress, AdvaMed Urge Physician-Industry Transparency BY LAUREN UZDIENSKI, JANUARY 7, 2009

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

Obama May Broaden Federal Funding for Stem Cell Research BY LAUREN UZDIENSKI, DECEMBER 8, 2008

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

With Polls Closed and Votes Counted, What's in Store for the Device Industry? BY LAUREN UZDIENSKI, NOVEMBER 5, 2008

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

GAO Report Could Shake Up the 510(k) Process BY LAUREN UZDIENSKI, OCTOBER 6, 2008

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

New Massachusetts Law Says Devicemakers Must Disclose Gifts to Physicians BY LAUREN UZDIENSKI, AUGUST 20, 2008

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

Industry Responds to the Physician Payment Sunshine Act BY CHARLES CAO, APRIL 15, 2008

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

New Legislation Could Challenge Supreme Court's Preemption Ruling BY LAUREN UZDIENSKI, MARCH 26, 2008

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

Musculoskeletal News Roundup 28-Feb-2008 BY LAUREN UZDIENSKI, FEBRUARY 28, 2008

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

The New York Times Questions Prodisc, Surgeons, Hospitals, Industry and FDA BY DAVID KRESSEL, JANUARY 30, 2008

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

Grassley Bill Would Require Device Prices from Manufacturers BY LAUREN UZDIENSKI, NOVEMBER 6, 2007

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

MDMA Celebrates 15 Years: Past Achievements and Looking Ahead BY LAUREN UZDIENSKI, MAY 21, 2007

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

Congress, Industry Aim to Broaden Pediatric Device Research BY LAUREN UZDIENSKI, APRIL 4, 2007

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

New NJ Bill would Require Patient Consent for Reprocessed Devices BY LAUREN UZDIENSKI, JANUARY 28, 2007

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

MDMA Looks Ahead: MDUFMA, Reimbursement, Gainsharing and More BY LAUREN UZDIENSKI, JANUARY 22, 2007

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

Medical Device Regulatory Updates in China and Japan BY HUYEN NGUYEN, OCTOBER 9, 2006

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

Group Purchasing Organizations and Market Reform: What's Ahead for Device Companies? BY EDITOR, SEPTEMBER 5, 2006

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

Physician Income Cut BY LAING RIKKERS, AUGUST 11, 2006

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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