Conference Calendar

November 5-8 - American Academy of Implant Dentistry

November 7-9 - American Association of Hip and Knee Surgeons

Complete Calendar »

Earnings Calendar

Nov 3 @ 4:30 PM ET - Integra LifeSciences Holdings Corporation

Nov 5 @ 4:30 PM ET - Wright Medical Group Inc

Complete Calendar »

Read our research via:
email art

Weekly Email

rss art

RSS



app icon

iPhone

app store icon

Kindle



Orthopedic and Dental Industry News Complete Archive »

Reimbursement

Humana Sues Medtronic Over Marketing Strategy of INFUSE BY ANDREW VAHRADIAN, JUNE 9, 2014

Last week, Humana filed a lawsuit against Medtronic accusing the defendant of falsely representing its INFUSE Bone Graft product as "safe and effective" in spinal fusion surgeries. INFUSE is Medtronic's proprietary formulation of recombinant human bone morphogenetic protein-2 (rhBMP-2), which... more

CMS Issues Proposed IPPS Regulation Changes for FY2015 BY ANDREW VAHRADIAN, MAY 1, 2014

The Centers for Medicare & Medicaid Services (CMS) issued the proposed rule for the FY2015 Inpatient Prospective Payment System (IPPS), which sets Medicare payment policies and rates for inpatient procedures at general acute care and long-term care hospitals (LTCHs). The... more

CMS to Begin Disclosing Medicare Procedure Data Publicly BY ANDREW VAHRADIAN, APRIL 10, 2014

The Centers for Medicare & Medicaid Services (CMS) announced a new policy in which the federal agency will begin publicly disclosing data on Medicare services and procedures furnished by individual physicians and other professionals in order to make the U.S.... 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

CMS Releases IPPS Proposed Rule for FY2014 BY ANDREW VAHRADIAN, MAY 1, 2013

The Centers for Medicare and Medicaid Services (CMS) issued its proposed FY2014 rule regarding Medicare payment policies and rates paid to acute-care hospitals through the Inpatient Prospective Payment System (IPPS) in support of operating and capital-related costs associated with inpatient... more

Chinese Governmental Expenditure on Healthcare Anticipated to Rise BY ANDREW VAHRADIAN, APRIL 25, 2013

Two independent industry reports illustrate encouraging signs regarding the development of the healthcare industry in China, indicating that healthcare spending in the country will increase substantially in future years. Industry analysts at KPMG anticipate that Chinese governmental expenditure on pharmaceuticals,... more

Fiscal Cliff Legislation Blocks Physician Pay Cuts BY LAUREN UZDIENSKI, JANUARY 7, 2013

The fiscal cliff package of legislation passed on January 1st will avert scheduled cuts to physician Medicare pay, though this time, hospitals will pick up the slack. The latest round of cuts was scheduled to reduce physician pay by 26.5%, which amounts to around $30 billion over the next decade. Cuts to hospital pay will make up some of the difference, with Medicare pay to hospitals for inpatient care to be reduced by about $10.5 billion over the next ten years. Reductions to Medicaid pay to hospitals will save an additional $4.2 billion over the same period. more

2013 Reimbursement Rates Finalized, Higher than Proposed Rates BY LAUREN UZDIENSKI, AUGUST 7, 2012

CMS, which sets annual reimbursement rates for Medicare, released last week the final 2013 pay rates. The final rule was generally in line to slightly improved from rates proposed in the spring. more

Orthopedic Device Patterns Among Medicare Beneficiaries BY LAUREN UZDIENSKI, JULY 16, 2012

Responding to a request from Senator Orrin Hatch (R-Utah), the U.S. Government Accountability Office (GAO) provided a summary of implantable medical device trends among Medicare beneficiaries. The GAO found that about 1.6 million implantable device procedures were performed on Medicare patients in 2009, totaling about $20 billion in costs. Orthopedic and cardiac implantations were the most common device procedures, accounting for nearly all implantable-device-related Medicare spending in that year. This trend should continue as Medicare patients live longer and innovative devices enter the market. more

CMS Releases IPPS Proposed Rule for FY2013 BY LAUREN UZDIENSKI, APRIL 25, 2012

CMS released the FY2013 draft rule yesterday, and rate increases in orthopedics and spine are higher than they have been in the past couple of years. Payments for orthopedic and spine DRGs are expected to increase by around 3-4%, depending on the procedure, which compares to around a 1% increase for hospital payments overall. more

Musculoskeletal News Roundup 8-Mar-12 BY LAUREN UZDIENSKI, MARCH 8, 2012

Corin, MAKO report earnings ... NLT Spine raises $5.7M ... Baxano receives CE mark for iO-Flex ... Synthes receives FDA warning letter ... Amedica launches Procet Facet Allograft Implant ... Crosstrees Medical completes enrollment in IDE study for VCF treatment ... Titan Spine creates EU subsidiary ... Vexim establishes German subsidiary more

Latest Doc Pay Fix to Last Through 2012 BY LAUREN UZDIENSKI, FEBRUARY 22, 2012

Congress passed a new patch on physician payment legislation that will keep reimbursement rates stable through 2012, effectively putting the issue off until after the election this fall. The patch, which is included in a larger package of payroll and unemployment benefits, prevented pay cuts of more than 27%. The government will spend about $20 billion to maintain pay rates, with the funds to come from the Medicaid budget as well as obesity and smoking prevention programs created by President Obama's healthcare reform legislation. 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

TranS1 Announces Positive Reimbursement Decision BY LAUREN UZDIENSKI, DECEMBER 14, 2011

TranS1 announced this morning that Medicare Administrative Contractor Palmetto GBA has reversed a prior non-coverage decision for the company's AxiaLIF and will now reimburse the procedure. Palmetto covers approximately nine million people in California, Virginia, North Carolina, South Carolina, Nevada, West Virginia and Hawaii. more

CMS to Pre-Review Ortho, Cardio Procedures in 11 States BY LAUREN UZDIENSKI, DECEMBER 5, 2011

CMS has announced a new strategy against unnecessary procedures, initiating a demonstration wherein the Medicare payor will review and approve scheduled procedures in 11 states. The chosen states include Florida, California, Texas, New York and Ohio and were selected based on "high populations of fraud- and error-prone providers" or a large number of claims for short hospital stays. Analysts have raised concerns that pre-certifying cases will be burdensome for hospitals and may suppress procedure volumes. more

FDA, CMS Launch Joint Review Pilot BY LAUREN UZDIENSKI, OCTOBER 11, 2011

"Safe and effective" and "reasonable and necessary" will align in a new pilot program from the FDA and CMS. The two agencies will test the joint review of medical devices, enabling Medicare reimbursement coverage to coincide with market approval. Historically,... more

HHS Introduces Bundled Payments Pilot for Inpatient Surgical Procedures BY LAUREN UZDIENSKI, AUGUST 29, 2011

The U.S. Department of Health and Human Services introduced a new pilot program that will bundle payments for inpatient services delivered across an episode of care, such as hip replacement, rather than paying for services separately. more

CMS Releases Draft IPPS Rule for FY2012 BY LAUREN UZDIENSKI, APRIL 20, 2011

Yesterday afternoon, CMS released their draft IPPS rule for the upcoming fiscal year. After fairly substantial increases in pay last year, proposed pay for spine and orthopedic DRGs are moderating somewhat for FY2012. Despite a 3% increase in kyphoplasty/vertebroplasty, spine fusion looks roughly flat; further, trauma is flat, and recon is slated to receive a slight decrease in pay. more

FDA Issues Non-Approvable Letter for Medtronic's Amplify BY SANDER DUNCAN, MARCH 11, 2011

Medtronic disclosed in its 10-Q on Wednesday that the FDA issued a non-approvable letter for Amplify, its new BMP-2 product. Medtronic was seeking a postero-lateral fusion indication for Amplify, for which Infuse, its other BMP product, is already widely-used off-label. more

Musculoskeletal News Roundup 16-Dec-10 BY LAUREN UZDIENSKI, DECEMBER 16, 2010

Theken Spine wins Ohio grant . . . Ellipse Technologies receives CE mark for the PRECICE limb lengthening device . . . Memometal Technologies launches MemoDerm Acellular Dermal Matrix and Smart Toe II Hammertoe Fixation System . . . Zimmer receives reimbursement premium from Japan for the Trabecular Metal Modular Cup . . . Stryker files patent infringement suit against Zimmer . . . Lanx appoints CEO 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

MEDCAC Vote on Off-Label BMP Use Shows Lack of Confidence in Supporting Evidence BY SANDER DUNCAN, SEPTEMBER 23, 2010

On Wednesday, the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) met to discuss the existing body of evidence on BMPs, particularly when it is used off-label. The panel's vote on their confidence in the adequacy of the data published... more

Musculoskeletal News Roundup 23-Sept-10 BY LAUREN UZDIENSKI, SEPTEMBER 23, 2010

M&A Amedica acquired US Spine for an undisclosed amount. The target company manufactures a range of fusion products as well as the Facet Fixation System, which features the Facet Gun to lock the facet joint. Amedica says that with the... more

FDA and CMS Propose Simultaneous Reviews BY LAUREN UZDIENSKI, SEPTEMBER 20, 2010

The FDA and CMS are considering overlapping reviews of new products, which the agencies say could reduce the time between marketing and reimbursement decisions. 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

Musculoskeletal News Roundup 5-Aug-10 BY LAUREN UZDIENSKI, AUGUST 5, 2010

ATEC, ARTC, BMTI, DJO, EXAC, MAKO, VITA, RTIX, SNN, SMA, TSON, WMGI report 2Q:10 . . . Bacterin closes private placement . . . Wright Medical launches the EVOLUTION Medial-Pivot Knee . . . VertiFlex enrolls 150th patient in their IDE study more

CMS Releases Final 2011 Payment Increases for Ortho BY SANDER DUNCAN, AUGUST 2, 2010

CMS released a final rule for FY 2011 IPPS policies and payment rates, increasing their proposed ortho payments released in April. Large joint reimbursement increased to an average of $15,320 in FY 2011, up 1.3% over FY 2010. Rates for... 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

President Obama Urges Congress to Pass Doc Fix BY LAUREN UZDIENSKI, JUNE 14, 2010

A 21% reduction to physician Medicare pay is set to take effect this week if Congress doesn't act to avert the reduction, and President Obama is lobbying legislators to block the cuts. In his weekly radio address, the president said that the majority of Congress is prepared to avert cuts, adding that Senate Republicans were holding up legislation that would raise pay by 2% this year. The GOP counters that the cost of the bill is too great. 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

CMS Proposes 2011 Payment Increases for Ortho BY LAUREN UZDIENSKI, APRIL 20, 2010

CMS%20log%20blue.jpgYesterday CMS released its draft IPPS rule for FY 2011, and pay rates look to be increasing in ortho following relatively flat growth from FY2009 to FY2010. more

Congress Delays CMS Pay Cut - For Now BY LAUREN UZDIENSKI, APRIL 19, 2010

On Thursday Congress voted to delay a scheduled 21% cut to CMS payments until June 1. The pay decreases have technically been in place since April 1, though CMS has not been processing claims, anticipating that Congress would act to block the cuts. more

Musculoskeletal News Roundup 25-Mar-10 BY LAUREN UZDIENSKI, MARCH 25, 2010

Bovie Medical, Custom Spine receive FDA clearances . . . Stryker resolves an FDA warning letter . . . Aesculap launches Spyder MIS retractor system . . . RTI Biologics opens reimbursement hotline . . . NASS surveys spine physicians about Medicare cuts . . . ConMed, Smith & Nephew and Stryker ink deals with Premier Purchasing Partners more

Musculoskeletal News Roundup 4-Mar-10 BY LAUREN UZDIENSKI, MARCH 4, 2010

knee.jpg Corin, Osteotech and Integra report 4Q . . . Baxter to acquire ApaTech for up to $330.0 million . . . Intrinsic Therapeutics closes on $18.0 million of a $20.0 million round . . . FDA schedules Orthopaedic and Rehabilitation Devices Panel meeting for Menaflex . . . Aetna and United Healthcare reverse prior policies and announce that they will cover NuVasive's XLIF . . . Congress delays Medicare pay cut more

Aetna, UHC Reverse Payment Policies for XLIF BY LAUREN UZDIENSKI, MARCH 2, 2010

nuvasive_logo_small.jpgAetna and United Healthcare both announced that they will cover XLIF, reversing non-coverage policies and allowing the procedure to shed its "investigational" status. more

Blue Cross and Blue Shield Names Spine, Large Joint Centers to its Blue Distinction Program BY LAUREN UZDIENSKI, FEBRUARY 16, 2010

Blue Cross and Blue Shield announced that they would broaden their "Blue Distinction" designation granted to high-performing hospitals to include spine and hip and knee centers. Blue Distinction hospitals have met objective, "evidence-based thresholds for clinical quality and safety" and... more

ReGen's Menaflex to Receive a CMS National Coverage Decision BY LAUREN UZDIENSKI, SEPTEMBER 1, 2009

CMS announced this week plans to initiate a national coverage determination on ReGen Biologics' Menaflex, a collagen scaffold for the treatment of meniscal tears. NCDs are relatively uncommon, with CMS issuing 18-24 decisions each year, and few of them relate... more

CMS Rate Increase a Positive for Spine and Ortho BY JOHN MCCORMICK, AUGUST 3, 2009

Late Friday afternoon, CMS issued their final rule for FY2010 for inpatient reimbursement rates. When we reviewed specific areas of spine, the rule turned out to be a boost compared to their April proposal. Spine reimbursement rates were finalized at... more

DOJ Investigates Kyphoplasty Claims Over Alleged Medicare Violations BY LAUREN UZDIENSKI, JULY 16, 2009

According to the Report on Medicare Compliance, the DOJ is conducting an investigation into Medicare inpatient claims for kyphoplasty at hospitals nationwide. The probe stems from a whistleblower lawsuit from two former Kyphon sales and reimbursement managers who claimed that... more

Trans1 Pre-Announces Q2 Amid Reimbursement Changes BY LAUREN UZDIENSKI, JULY 13, 2009

Trans1 pre-announced 2Q:09 sales in the range of $7.9 to $8.0 million, below guidance of $8.7 to $9.0 million and missing analyst projections of $8.8 million. 2Q is also down sequentially from 1Q:09's $8.7 million. Second quarter sales increased 33%... more

CMS Proposes Changes to Physician Payment Schedule BY LAUREN UZDIENSKI, JULY 6, 2009

CMS announced last week the draft 2010 physician payment schedule, which includes a proposed 20% payment reduction to physicians. However, as has happened in the past, legislative action is always possible to prevent these dramatic cuts. It should also be... 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

CMS Proposes Payment Increases for 2010 BY LAUREN UZDIENSKI, MAY 4, 2009

CMS released its draft FY2010 IPPS schedule on Friday. At a glance, the 1,200-page document seems to bode well for ortho, and relatively significant payment increases may help offset some of the concerns about pricing pressure that have dogged the... 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

Hospitals and the Credit Markets: An Interview with Wachovia's Mike Matson BY JOHN MCCORMICK, NOVEMBER 5, 2008

Earlier this week we interviewed Wachovia's industrious medical technology and device analyst Mike Matson to revisit his thoughts on how the credit market dislocations are affecting hospital capital spending decisions. McCormick: Mike, thank you for joining us especially with all... more

New York Times Questions the Safety, Efficacy of 510(k)s BY LAUREN UZDIENSKI, OCTOBER 27, 2008

The New York Times has joined a chorus of concern over the 510(k) process, suggesting in an article yesterday that 510(k)s are outdated (FDA device laws were passed "when devices played a much smaller role in medicine") and allow new... more

Medical Tourism at Home: U.S. Hospitals Competing with Foreign Pricing BY LAUREN UZDIENSKI, SEPTEMBER 10, 2008

The Wall Street Journal this morning revealed a new variation on medical tourism: patients are traveling for medical procedures, though not overseas. Medical tourism arose from skyrocketing U.S. healthcare costs; a hip replacement can cost $43,000 domestically and a mere... more

Musculoskeletal News Roundup 21-Aug-08 BY LAUREN UZDIENSKI, AUGUST 21, 2008

Earnings Kensey Nash reported FQ4:08 revenues of $22.0, representing a 29% increase over FQ4:07 and beating estimates by $1.0 million. Biomaterials were up 37% to $13.3 million, which was attributed to strong growth in the orthopedic and cardiovascular product lines.... more

Orthopedic Procedures May Receive CMS National Coverage Decisions BY LAUREN UZDIENSKI, AUGUST 5, 2008

CMS released a list last week of 19 potential topics for National Coverage Decisions. These topics include a number of orthopedic devices: Artificial cervical discs Bone morphogenetic protein Hip resurfacing Vertebroplasty and kyphoplasty Lumbar fusion for degenerative disc disease As... more

Musculoskeletal News Roundup 24-July-08 BY LAUREN UZDIENSKI, JULY 24, 2008

Earnings Anika Therapeutics reported 2Q:08 revenue of $8.38 million, representing a 32% increase over 2Q:07 but missing estimates by $0.4 million. The company attributed sales growth to the strength of the Orthovisc line. Net income for 2Q:08 was $0.81 million,... more

CMS Proposes National Non-Coverage Decision for IDET BY LAUREN UZDIENSKI, JULY 24, 2008

CMS proposed a national non-coverage decision for intradiscal electrothermic therapy (IDET), saying there is insufficient evidence that the procedure improves outcomes in the Medicare population. IDET is a minimally-invasive treatment for low back pain where a catheter and a heating... more

Musculoskeletal News Roundup 17-July-08 BY LAUREN UZDIENSKI, JULY 17, 2008

Earnings Biomet reported FQ4:08 revenues of $635.6 million, an increase of 16% (10% constant currency) over the year-ago period. Sales increased 10% in the U.S and 24% (11% constant currency) OUS. Recon sales increased 17% worldwide (12% constant currency) to... more

In a Turnaround, Senate Votes to Block Medicare Payment Cuts BY LAUREN UZDIENSKI, JULY 10, 2008

This year's saga of Medicare reimbursement cuts seems to be heading for a happy ending this week, as the Senate voted yesterday to block the scheduled 10.6% cut to payments (reversing a determination from several weeks ago that the cuts... more

House Votes to Block a 10% Cut to Physician Payments BY HAL BRIGHAM, JUNE 26, 2008

Despite threats of a presidential veto, the House resoundingly passed a bill Tuesday blocking a 10% cut in Medicare’s reimbursement payments to physicians. In addition to protection against the cut, which was scheduled to take effect July 1, the bill... more

New Swiss Spine Registry Could Shape Practice Habits, Reimbursement BY LAUREN UZDIENSKI, MAY 27, 2008

In Switzerland, more than 135 surgeons are contributing data to a newly-implemented spine registry, reporting cost, efficacy and performance information on cervical and lumbar total disc arthroplasty and kyphoplasty procedures. The Swiss government started the program in December 2007 to... more

CMS Introduces Acute Care Episode Demonstration for Orthopedics BY LAUREN UZDIENSKI, MAY 21, 2008

Hoping to "align financial incentives" between hospitals and physicians, CMS announced plans for an Acute Care Episode (ACE) demonstration that will feature bundled payments for the treatment of certain orthopedic and cardiac patients. CMS argues that bundling, compared to paying... more

Study Forecasts Strong Growth in Public Spending as Boomers Join Medicare BY LAUREN UZDIENSKI, MAY 5, 2008

Health Affairs recently reported on health spending projections through 2017, and the next decade is characterized by steady growth and a particular strength in public spending as baby boomers begin to enroll in Medicare. Health spending is reported to have... more

Musculoskeletal News Roundup 17-Apr-08 BY LAUREN UZDIENSKI, APRIL 17, 2008

Earnings Biomet reported FQ3:08 net sales of $603.1 million, a 14% increase over the year-ago period. Excluding the impact of foreign currency, net sales increased 10%. U.S. revenue was $351.6 million. Adjusted net income for the third quarter was $25.2... more

CMS Proposes 2009 Payment Increases BY JOHN MCCORMICK, APRIL 15, 2008

On Friday, CMS released its draft 2009 Inpatient Prospective Payment System, and the document indicates significant payment increases for orthopedic procedures. The rate at which the payments are increasing is also up when compared to 2008. Per the proposal: -Spine... more

As Boomers Retire, Physician Shortages and Reimbursement Cuts Loom BY LAUREN UZDIENSKI, APRIL 15, 2008

A new report from the Institute of Medicine (IOM) calls the U.S. healthcare system unprepared for the aging of baby boomers, citing a lack of trained healthcare workers and few economic benefits to treating geriatric patients. Medicare will begin to... more

CMS Altering Payment Model; Parallel Review with FDA on "Front Burner" BY LAUREN UZDIENSKI, APRIL 8, 2008

CMS is currently transitioning to a pay-for-performance system, with payments based on quality and efficiency metrics, according to comments made by CMS Chief Medical Officer Barry Straube and first reported by FDAnews. Straube added that voluntary reporting of quality measures... more

Musculoskeletal News Roundup 21-Feb-08 BY LAUREN UZDIENSKI, FEBRUARY 21, 2008

Earnings ArthroCare reported 4Q:07 revenues of $87.5 million, beating estimates by $1.7 million, representing a 25% increase over the year-ago period. Net income was $14.5 million, or $0.50 per diluted share, missing estimates by a penny and representing a 78%... more

ArthroCare in the News Again with the Acquisition of DiscoCare BY LAUREN UZDIENSKI, JANUARY 9, 2008

Last week ArthroCare announced a $25 million deal to acquire DiscoCare, described in the press release as a "medical billing and reimbursement service provider." Specifically, DiscoCare provides reimbursement assistance to physicians using Arthrocare's plasma disc decompression (PDD) device; though it... more

Highlights from MDMA's 2007 Reimbursement Meeting BY LAUREN UZDIENSKI, NOVEMBER 19, 2007

Last week we among more than 75 attendees at MDMA's 10th Annual Reimbursement Conference, where topics included establishing a comprehensive reimbursement strategy, updates from CMS and advice on complying with fraud and abuse regulations in consultant relationships. One of the... more

JBJS: U.K. NICE Guidelines Have "Little Impact" on Surgeons' Product Selection BY LAUREN UZDIENSKI, SEPTEMBER 10, 2007

The July U.K. edition of JBJS reported results of a study evaluating the impact of the U.K.'s National Institute for Health and Clinical Excellence (NICE) guidelines for hip replacements. NICE publishes guidelines to promote "good health and the prevention and... more

Musculoskeletal News Roundup 16-Aug-07 BY LAUREN UZDIENSKI, AUGUST 16, 2007

Earnings BioMimetic Therapeutics reported a 2Q:07 net loss of $6.4 million, or $(0.35) per share, beating estimates of $(0.39) per share and improving from a net loss of $3.9 million, or $(0.42) per share, in 2Q:06. 2Q:07 Revenues were $0.5... more

CMS Issues Final Non-Coverage Decision for Lumbar Artificial Discs BY LAUREN UZDIENSKI, AUGUST 15, 2007

CMS released its final decision on lumbar artificial disc replacement (LADR) procedures yesterday. As we predicted, the final decision does not deviate from the proposed decision, with CMS finding that LADR is not reasonable and necessary for the Medicare population... more

Musculoskeletal News Roundup 2-August-07 BY LAUREN UZDIENSKI, AUGUST 2, 2007

Earnings Large Joint: Exactech announced 2Q:07 revenue of $31.6 million, beating estimates of $29.9 million and up 19% from the comparable quarter. CEO Bill Petty attributed the growth to "acceptance of our new products and continuing success of our products... more

CMS Finalizes 2008 Reimbursement Increases BY LAUREN UZDIENSKI, AUGUST 2, 2007

CMS released its final rule for the FY2008 Inpatient Prospective Payment System (IPPS). As we noted when the draft rule was announced in April, ortho payments will mostly increase next year. The rule also confirms that CMS will implement new... more

Musculoskeletal News Roundup 26-July-07 BY LAUREN UZDIENSKI, JULY 26, 2007

Earnings Stryker reported revenues of $1.46 billion, beating estimates of $1.44 billion and increasing 16% from $1.26 billion in 2Q:06. 2Q:07 earnings were $269.1 million, or $0.65 per share, beating estimates of $0.61 and up from $0.52 in the comparable... more

CMS Revises their Clinical Trial Policy; More Changes to Come BY LAUREN UZDIENSKI, JULY 13, 2007

On Monday, CMS released a brief Decision Memo on changes to the agency's Clinical Trials Policy. The proposed decision was first announced in April and followed by a public comment period. The memo notes two important changes. One, the final... more

Los Cabos: An Expansive Spine Meeting BY JOHN MCCORMICK, JULY 9, 2007

The week prior to the 4th, we attended the Spine Technology Education Group meeting in Los Cabos, Mexico, which addressed numerous topics on innovative techniques in spine surgery. Kudos to Drs. Phillips, Albert and Vaccaro for organizing a meeting that... more

Orthopedic News Roundup 31-May-07 BY LAUREN UZDIENSKI, MAY 31, 2007

Regulatory CMS released a proposed non-coverage decision for lumbar artificial disc replacements following a review of Synthes' Pro-Disc-L. The agency found that LADR is not reasonable and necessary for Medicare recipients over 60 based on lack of relevant data and... more

On the CMS Lumbar Disc Non Coverage Proposal BY JOHN MCCORMICK, MAY 29, 2007

At the end of Friday, CMS published a sweeping proposal that denies coverage for all lumbar artificial discs in the age 60-and-over Medicare population. The proposal can be found here on the CMS website. Falling into line with its previous... more

Orthopedic News Roundup 19-Apr-07 BY LAUREN UZDIENSKI, APRIL 19, 2007

Earnings Stryker announced 1Q:07 earnings on Wednesday. Net income increased to $243.5 million, or $0.59 per share, beating analysts' estimates of $0.58 per share. In the comparable quarter, net income was $147.5 million, or $0.36 per share. Revenues increased 13%... more

CMS Proposes 2008 Increases BY JOHN MCCORMICK, APRIL 16, 2007

Late Friday, the Centers for Medicare and Medicaid Services (CMS) released the proposed 2008 Inpatient Prospective Payment System (IPPS) under which US hospitals are reimbursed under the DRG codes. As with prior years, this release is a draft statement and... more

Spine Reimbursement: Lehman Brothers visits with CMS BY JOHN MCCORMICK, APRIL 2, 2007

The Lehman Brothers medical device research team had a fruitful visit to the beltway last week notably with Steve Phurrough, Director of the Coverage and Analysis Group at CMS and Herb Khun, CMS's Deputy Administrator. One of Lehman's findings related... 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

Yet Again, Synvisc Will Not Have To Share Reimbursement Code BY ARIELLA P. GOLOMB, MD, DECEMBER 15, 2006

In October we reported that Genzyme, maker of the viscosupplement Synvisc, announced a CMS decision grouping all industry viscosupplementation products into the same reimbursement code in January 2007. The coding change meant that reimbursement for viscosupplementation treatments will be based... more

Medicare Panel Debates Spinal Fusion Study Design BY JOHN MCCORMICK, DECEMBER 1, 2006

Yesterday we attended the the Medicare Coverage Advisory Committee (MCAC) meeting on spinal fusion at the Centers for Medicare and Medicaid Services (CMS) in Baltimore, MD. The purpose of the meeting was to determine the type of data needed to... more

Intial SPORT Trial Outcomes Subject to Interpretation, but Tend to Favor Surgery BY JOHN MCCORMICK, NOVEMBER 22, 2006

The first arm of the Spine Patients Outcome Research Trial ("SPORT") study was released by the Journal of the American Medical Association yesterday. The $13.5 million NIH funded SPORT study has been designed to determine the efficacy of spine surgery... more

MDMA Conference Provides Reimbursement Advice BY ARIELLA P. GOLOMB, MD, NOVEMBER 13, 2006

Last week we attended the 9th Annual MDMA Coverage Reimbursement and Health Policy Conference in Washington D.C. As we've previously discussed, the MDMA events are a terrific opportunity for small- to medium-sized device companies to network, provide insight on topical... more

Orthopedic News Roundup 2-Nov-06 BY HUYEN NGUYEN, NOVEMBER 3, 2006

Earnings Biologics: Orthovita reported 3Q:06 product sales came in at $11 million, up 32% compared to 3Q:05. Net loss for the quarter was $3.7 million, or a loss of $0.07 per share. The Company beat analysts' EPS estimates by $0.02,... more

Synvisc To Share Reimbursement Code BY ARIELLA P. GOLOMB, MD, OCTOBER 31, 2006

In a press release yesterday, Genzyme, maker of Synvisc, announced a CMS decision that would group all viscosupplementation products into the same reimbursement code in January 2007. The company stated that they would fight hard to dispute this decision (through... more

How Are Orthopedic Surgeons Being Incentivized For Academic Productivity? BY ARIELLA P. GOLOMB, MD, OCTOBER 16, 2006

In the wake of demands for increasing clinical volume, decreases in physician income and increasing malpractice costs, it is even more critical to incentivize physicians to perform academic activities that do not directly generate revenue (teaching, research and service) but... 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

McClellan to Leave CMS BY ARIELLA P. GOLOMB, MD, SEPTEMBER 5, 2006

In an email to his staff today, Mark B. McClellan, MD, PhD, Administrator of the Center for Medicare and Medicaid Services (CMS) since March 2004 announced that he will be leaving CMS by early October. Dr. McClellan did not announce... 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

Orthopedic News Roundup 3-Aug-06 BY HUYEN NGUYEN, AUGUST 3, 2006

Earnings: Biologics: IsoTis OrthoBiologics reported 2Q:06 revenue of $10.8 million, up 43% compared to $7.5 million in 2Q:05. Its U.S. division grew 22%, while international revenues grew 39%. The Company has three distribution channels: U.S. independent agents, international distributors and... more

Medical Device Space Breathes Sigh of Relief as CMS Issues Inpatient Reimbursement Revisions BY TODD BARTELS, AUGUST 3, 2006

As we have previously discussed in several posts, since April the Center for Medicare and Medicaid Services (CMS) has planned to release new Inpatient Prospective Payment System (IPPS) regulations for FY 2007. Late Tuesday CMS issued this much-anticipated IPPS rule,... more

US Set to Catch Up with International Coding Standards BY TODD BARTELS, AUGUST 1, 2006

As we have previously discussed, the US government for some time has been under pressure to adopt international coding standards that have been used by many other countries for over a decade. Finally, last Thursday Congress passed legislation ensuring that... more

CMS To Revise Inpatient Prospective Payment System (IPPS) BY NICK ADAM, JULY 22, 2006

The Centers for Medicare & Medicaid Services (CMS) will make its final ruling on the proposed changes to the Inpatient Prospective Payment System (IPPS) on August 1st, 2006. The proposed changes, to be implemented by FY 2008, are the first... more

When Will the US Catch Up with International Coding Standards? BY ARIELLA P. GOLOMB, MD, JUNE 19, 2006

The International Classification of Diseases (ICD), which is overseen by the World Health Organization, is the international standard diagnostic classification for all general epidemiological and many health management purposes. ICD-10 was adopted in the US in 1999 for reporting mortality,... more

A Voice for Innovation: MDMA BY LAING RIKKERS, JUNE 16, 2006

On June 14th and 15th, we attended the Medical Device Manufacturers Association (MDMA) Annual Meeting. The organization provides medical device entrepreneurs an opportunity to have their voices heard on the hill. Innovation in our industry generally comes from the smaller... more

Who's Who of the Medical Device Lobby BY ARIELLA P. GOLOMB, MD, JUNE 14, 2006

The Hill, "The Newspaper for and about the U.S. Congress", posted on its website last week a list of 14 top medical device industry lobbyists. Leading this list is Stephen Ubl, who is seen as "a triple-A superweight." Newly appointed... more

Orthopedic News Roundup 25-May-06 BY HUYEN NGUYEN, MAY 25, 2006

Appointment: IsoTis OrthoBiologics appointed Barbara Boyan to its Board of Directors. Ms. Boyan is a co-founder of OsteoBiologics, Inc. (OBI) and a professor in the Wallace H. Coulter Department of Biomedical Engineering at the Georgia Institute of Technology and at... more

Preparing for P4P BY LAING RIKKERS, MAY 23, 2006

Pay for performance (P4P) comes up over and over again in reimbursement discussions. In the May 2006 edition of Orthopedics Today, there is an in-depth review of what hospitals, surgeons and other stakeholders should know about P4P. As a reminder,... more

CMS Changes its Charite Decision BY DAVID KRESSEL, MAY 17, 2006

In a surprising but welcome change of heart, the Centers for Medicare and Medicaid Services revised its proposed National Noncoverage Decision and will reimburse the Charite in specific circumstances. In the February draft of the NCD, CMS proposed national noncoverage... more

Report Warns Medicare Exhausted in 12 Years BY LAING RIKKERS, MAY 2, 2006

The Medicare trust fund will be exhausted in 12 years, according to the trustees' annual report released yesterday. This is two years earlier than the results published a year ago. The cited causes of reduced funding are not unfamiliar-- rising... more

The Proposed Change in Medicare Inpatient Reimbursement Expected to Impact Profitability of Specialty Hospitals BY MARTIN GOLD, APRIL 24, 2006

[Editor's note: We welcome regulatory expert Martin Gold as a guest blogger. See his profile here.] The recently published proposed change in inpatient Medicare payment is expected to have a significant financial affect on hospitals that specialize in cardiac and... more

CMS Proposed Rule for Orthopedics Procedures for FY 2007 BY HUYEN NGUYEN, APRIL 17, 2006

Last week The Centers for Medicare & Medicaid Services (CMS) issued a report on a revised proposed rulemaking of the Inpatient Prospective Payment System (IPPS). The proposed rule highlights changes and updates for Diagnosis Related Groups (DGRs) in orthopedic surgeries:... more

Medical Device Trade in Foreign Markets -- Investigation BY HUYEN NGUYEN, APRIL 5, 2006

The U.S. International Trade Commission (ITC) issued a press release yesterday announcing the launch of a fact-finding investigation into conditions affecting U.S. trade of medical devices and equipment in principal foreign markets, particularly the Japanese market. The House Ways and... more

Adverse Selection and Employer Based Insurance Markets [EDITORIAL] BY JOHN MCCORMICK, APRIL 5, 2006

Any microeconomics 101 course worth its salt will try to provide examples of market failure. The most potent market failure arguments can tied to real world problems of information economics where one of the more famous examples used is "adverse... more

A Surgeon's Look at Costs In Total Joint Arthroplasty BY LAING RIKKERS, MARCH 31, 2006

One of the most informative sessions at AAOS was a section of the Health Policy Update Symposium delivered by William L. Healy, M.D. of the Lahey Clinic. Healy gave real-life examples of the complicated and delicate balance of hospital economics,... more

CMS Proposes National Noncoverage of Charite BY DAVID KRESSEL, FEBRUARY 17, 2006

The Centers for Medicare and Medicaid Services published a Proposed Decision Memo for Lumbar Artificial Disc Replacement. Their conclusion: The Centers for Medicare and Medicaid Services (CMS) is seeking public comment on the proposed determination that the evidence is not... more

Moratorium on Specialty Hospitals Continues BY DAVID KRESSEL, FEBRUARY 15, 2006

Since 2003, there has been a moratorium on new construction of physician-owned specialty hospitals. The ban was continued after its first 18 month term, and now it has been renewed for a second time. In the "Deficit Reduction" bill that... more

Outsourcing in Health Insurance BY SHELLY ACHAIBAR, DECEMBER 15, 2005

The rising cost of health insurance is a significant issue in the United States. Roughly 45 million people are uninsured and Medicare and Medicaid are chronically under funded. Private insurance has become big business and spending has risen faster than... more

Orthopedic News Roundup 8-Dec-05 BY HUYEN NGUYEN, DECEMBER 8, 2005

Due to last week's Merrill Lynch investor conference (subscription may be required), investors have regained confidence in the orthopedic sector after the industry faced some hurdles within the past few months. In our HealthpointCapital Weekly Valuation Index, P/E (price-to-earnings) jumped... more

Update on Pricing Trends BY DAVID KRESSEL, DECEMBER 5, 2005

Last week, Merrill Lynch hosted its Med Tech Fundamentals Conference. One noteworthy session was the Reconstructive Orthopedics Panel. Participants were an industry "Who's Who": the CEO of Biomet, Chairman of Depuy (J&J), President of Smith and Nephew Orthopaedics, CEO of... more

The Latest on Reimbursement BY KAREN FEDER, NOVEMBER 18, 2005

Last week, we attended the 8th Annual Coverage and Reimbursement Conference in Washington, DC organized by MDMA, the Medical Device Manufacturers Association. Here's what we learned: Mark Miller, PhD., MedPAC Executive Director, talked about MedPAC recommendations to Congress to optimize... more

Orthopedic News Roundup 3-Nov-05 BY HUYEN NGUYEN, NOVEMBER 3, 2005

We wrap up this quarter with aggregated earnings and sales in the public orthopedic sector of $560 million and $5 billion, respectively, as a few more companies reported this week. For 3Q:05, orthopedic sales were up by 13% ($5.0 billion... more

CMS Publishes Reimbursement Codes for Kyphoplasty BY JOHN MCCORMICK, NOVEMBER 3, 2005

Earlier this morning Kyphon (Nasdaq: KYPH) shouted from the mountaintop: CMS has posted new CPT codes for Kyphoplasty which effectively brings reimbursement to a national level. The codes include percutaneous vertebral augmentation, RVUs for additional thoracic of lumbar vertebral bodies,... more

Blue Shield of California Denies Lumbar Artificial Disc Coverage BY JOHN MCCORMICK, OCTOBER 31, 2005

Ten days ago California's Blue Cross and Blue Shield met and, based on the available evidence, decided they would not cover artificial disc replacements at this time. Some interesting technical discussions are posted here: Blue Cross Blue Shield April 2005... more

A Follow-Up Interview with Gerald 'Gary' Bisbee, CEO of ReGen Biologics, Inc. BY JOHN MCCORMICK, OCTOBER 6, 2005

One of the leaders in this emerging meniscus repair market is ReGen Biologics. We recently had a chance to do a catch up with Gary Bisbee, CEO of ReGen Biologics who we interviewed last year. Disclosure: Individual members of HealthpointCapital,... more

Reimbursement and Specialty Hospitals BY HUYEN NGUYEN, OCTOBER 5, 2005

The fate of specialty hospitals is an important topic for the orthopedic and cardiology industry because so many U.S. specialty hospitals are either orthopedic or cardiology-focused and their economic survival depends upon favorable reimbursement. On September 30th, we participated with... more

Call to Action: Local Non-Coverage Draft Policy for Artificial Discs BY KELLI HALLAS, OCTOBER 3, 2005

By Kelli Hallas Vice President of Field Reimbursement Services Emerson Consultants, Inc. [Editor's note: We welcome consultant Kelli Hallas as a guest blogger. See a profile of Emerson Consultants, Inc. here.] Last month CMS issued a National draft non-coverage decision... more

International Reimbursement: Japan BY DAVID KRESSEL, SEPTEMBER 26, 2005

We participated in a Deutsche Bank-hosted conference call with Edward Rozynski, formerly an international pricing and reimbursement expert with AdvaMed, and currently an independent advisor on international market access for medical device companies. The most interesting part of the discussion... more

Update on CMS's National Coverage Decision on Charite BY DAVID KRESSEL, SEPTEMBER 22, 2005

As discussed in Barb Peterson's guest blog, the Centers for Medicare and Medicaid Studies (CMS) received a letter from an internist and Professor of Medicine at Washington University, Dr. Richard Deyo, requesting a National Coverage Determination (NCD) of the Charite... more

CMS (Medicare) opens a National Coverage Determination (NCD) request to review coverage of the lumbar artificial disc BY BARB PETERSON, SEPTEMBER 14, 2005

[Update: We're moving this entry to the top of the blog since it is sparking a lot of interest from our readers.] more

Privatization of Healthcare in the United States? BY JOHN CHOPACK, AUGUST 31, 2005

There is no denying that healthcare costs continue to accelerate in the U.S. We would argue most of these costs are justified given the continuing technological advancements made within the entire healthcare arena including medical devices and biotechnology. However, we... more

Differentiating the Needs of Key Stakeholders to Obtain Reimbursement for New Technologies BY KELLI HALLAS, AUGUST 9, 2005

By Kelli Hallas Vice President of Field Reimbursement Services Emerson Consultants, Inc. [Editor's note: We welcome consultant Kelli Hallas as a guest blogger.] In order for new technologies to receive reimbursement in today's healthcare market, they must show substantial clinical... more

Orthopedic News Roundup 5-Aug-05 BY HUYEN NGUYEN, AUGUST 5, 2005

This week we finish off the first half of 2005 reporting season with 17 orthopedic companies* released their financial numbers. In 2Q:05, in an aggregated total, orthopedic revenues increased 16% ($3.8 billion vs. $3.2 billion) and a 25% increased in... more

CMS Denies Add-On Payments for Charite BY JOHN MCCORMICK, AUGUST 2, 2005

In an unambiguous statement yesterday, CMS took a hard line and denied add-on payments for J&J's Charite artificial lumbar disc. In this document on pages 309 - 322, CMS balanced numerous comments, studies and outcomes against each other and came... more

Healthcare Policy Conference Notes BY LAING RIKKERS, JUNE 30, 2005

Greetings from the SG Cowen and ISI Health Care Policy Conference in Washington D.C. It's been a full day covering Medicare, Medicaid, FDA, Specialty Hospital Policy and Gainsharing. We've heard from Representative Pete Stark (D-CA) and Senator Debbie Stabenow (D-MI),... more

CMS Approves Orthofix Application for External Fixation BY JOHN MCCORMICK, JUNE 28, 2005

This morning Orthofix announced that Centers for Medicare & Medicaid Services (CMS) approved the Company's request to modify its coding mechanisms to include specific coding for hospital procedures utilizing external fixation devices. As of October of this year, facilities will... more

Reimbursement Report -- Available for download BY KAREN FEDER, JUNE 8, 2005

February 2010 update: This report is no longer available for purchase. Learn more here. Reimbursement is one of those issues you might wish would go away. Bureaucratic, jargon-heavy, inefficient, not easy to learn, and mostly boring. For everyone who knows... more

CMS Proposes New Reimbursement Rates - DRG 209 Rate Increases by 2% BY JOHN CHOPACK, MAY 24, 2004

Center for Medicare and Medicaid Services (CMS) released its 2005 proposed payments for inpatient procedures on May 18th/2004. CMS is calling for a 2% increase in DRG 209 payments bringing the total payment to $10,034 up from $9,839 the year... more

We have launched coverage of Osteotech and Orthologic and we briefly examine why Medicare Reimbursement is such a minor influence on orthopedic pricing. BY EDITOR, MAY 19, 2003

Osteotech is in the midst of a significant turn-around year with sales expected to reach or exceed $96 million and for cash flow (defined as EBITDA) to clear $23 million. This stands in contrast to last year's $83 million in... more


Complete Archive