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Device Regulation Alert: Safety, Compliance and Reimbursement News Pharma Compliance Alert

Device Regulation Alert: Safety, Compliance and Reimbursement News

Published weekly, this free e-newsletter offers up-to-date information on hot topics and trends effecting the medical device and diagnostics industry. With a subscription to Device Regulation Alert, you will get comprehensive coverage of device regulation, compliance and risk management.

2009 | 2008 | 2007

Device Regulation Alert: Safety, Compliance and Reimbursement News

Issue 52, December 29, 2008

• FDA issues draft guidance on submissions for sterile devices

  The FDA updated and clarified in new draft guidance the procedures for reviewing pre-market...

• Credentialing requirements raise kickback concerns

  Healthcare industry credentialing requirements place a financial and administrative burden on...

Issue 51, December 22, 2008

• FDA issues final guidance on submissions of PMA supplements

  The FDA provided new criteria for medical device manufacturers to determine what type of pre-market...

• MN considering device disclosure requirements

  A Minnesota state senator would like to see the state’s disclosure law expand to include...

Issue 50, December 15, 2008

• Massachusetts council releases draft disclosure regulations

  The Massachusetts Public Health Council released a draft of regulations regulating medical device...

• Credentialing requirements continue to be concern for industry

  The relationship between the surgeon and the sales representative is vital to patient care...

• FDA: Innovative Neurotronics' response to warning letter incomplete

  Innovative Neurotronics did not completely resolve problems uncovered by an FDA inspection...

• Terumo Cardiovascular Systems recalls pediatric arterial cannulae

  Terumo Cardiovascular Systems issued a Class I recall for 21 lots of its Tenderflow Pediatric...

Issue 49, December 8, 2008

• OIG releases Semiannual Report to Congress

  During fiscal year (FY) 2008, government enforcement efforts led to 455 criminal actions and 337...

• Citizen group accuses device makers of illegal online marketing

  The Prescription Project, a non-profit watchdog group, petitioned the FDA to require Abbott...

• Senator investigating use of unapproved device

  Senator Charles Grassley (R-IA) wants to know if a Northwestern University teaching hospital...

• Cleveland Clinic to post physician ties to industry

  Cleveland Clinic is taking its own steps toward transparency regarding physicians’ ties to...

Issue 48, December 1, 2008

• Former medical device manager pleads guilty to misbranding

  Darnell Martin, 35, of Chicago, pleaded guilty to one count of making a false statement and one...

• Animas issues Class I recall for battery caps

  Animas is recalling battery caps used with the OneTouch Ping System, Animas 2020 Insulin Pump...

Issue 47, November 24, 2008

• FDA issues special control guidance for condoms

  The FDA outlines labeling recommendations for natural rubber latex condoms without spermicidal...

Issue 46, November 17, 2008

• DOJ investigating AtriCure marketing

  The Department of Justice (DOJ) is investigating allegations that AtriCure, Inc., improperly...

• Headphones interfere with pacemakers, defibrillators

  MP3 player headphones can cause potentially dangerous interactions with implantable cardiac...

• DOJ recovers $1.34B in fraud, false claims in FY 2008

  The Department of Justice (DOJ) recovered $1.34 billion through fraud and false claims settlements...

Issue 45, November 10, 2008

• CMS delays gainsharing

  CMS did not include gainsharing its 2009 Medicare Physician Fee Schedule and Hospital Outpatient...

• Senators investigating J&J payments

  Senators Charles Grassley (R-IA) and Herb Kohl (D-WI) are looking into Johnson &...

Issue 44, January 3, 2008

• BioMedix receives FDA warning letter

  BioMedix Vascular Solutions failed to follow current Good Manufacturing Practices at its St. Paul...

• Thoratec initiates recall of heart device

  Thoratec issued a worldwide correction for some of its HeartMate II Left Ventricular Assist...

Issue 43, October 27, 2008

• FDA issues public health watch for transvaginal placement of surgical mesh

  Nine surgical mesh manufacturers submitted more than 1,000 reports of complications associated with...

Issue 42, October 20, 2008

• C.R. Bard receives FDA warning letter

  The FDA cited C.R. Bard for failing to meet current Good Manufacturing Practices at its Humacao...

• GAO: FDA advisory boards would benefit from more outreach

  Expanded outreach efforts could help the FDA mitigate barriers to recruiting qualified advisory...

• Senators continue to investigate industry, physician ties

  Senators Charles Grassley (R-IA) and Herb Kohl (D-WI) are looking into industry payments to...

Issue 40, October 6, 2008

• Grassley questions NIH hiring of Tufts University professor

  Senator Charles Grassley (R-IA) accused well-known Tufts University heart specialist Marvin...

• GE warned for violating cGMPs

  General Electric’s (GE) Centricity Imaging and other Picture Archiving and Communication...

• Medtronic notification classified as Class I recall

  The FDA considers Medtronic’s safety alert about the proper connection of sutureless...

• OIG to focus on DME payments

  The OIG will review Medicare Part B claims for durable medical equipment, prosthetics, orthotics...

Issue 39, September 29, 2008

• Internet promotion subject to FDA review

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• Internet promotion subject to FDA review

  Physicians and patients obtain most of their information about products online, said James M. Wood...

• FDA releases draft guidance for trials of incontinence devices

  Medical device manufacturers should use a randomized, controlled trial to collect data to...

• Fall Prevention receives warning letter

  Fall Prevention Technologies failed to follow current Good Manufacturing Practices for its...

• Medicare pays billions in questionable DME claims

  Medicare reimbursed more than $1 billion for 18 different durable medical equipment (DME) items...

• Kickback allegations by former Medtronic attorney revealed

  Former Medtronic senior legal counsel Ami P. Kelley filed a lawsuit claiming the company offered...

Issue 38, September 22, 2008

• Senator questions ties between industry, cardiology group

  Senator Herb Kohl (D-WI) questioned the American College of Cardiology’s (ACC) ability to...

• FDA reopens comment period for hemostatic devices

  For the second time, the FDA is reopening the comment period on its proposed guidance concerning...

• FDA warns Kimberly-Clark

  Kimberly-Clark significantly changed 12 models of previously approved sterilization wraps and...

• Trade shows present potential promotional pitfalls

  Clinical or medical personnel should be on hand at trade shows to provide information about...

Issue 37, September 15, 2008

• O'Ryan Industries receives warning letter

  O’Ryan Industries allegedly distributed its Endo 150 endoscopic light source and Omega ST...

• Medtronic marketing investigated

  Medtronic became the fourth major manufacturer investigated for improperly marketing its bile duct...

• Spectranetics under investigation

  The FDA and Immigration and Customs Enforcement executed a search warrant at Spectranetics...

• Medtronic posts list of donations

  Medtronic posted a list of its charitable donations online for the first time, in part because of...

Issue 36, September 8, 2008

• Rotech settles fraud charges

  Rotech Healthcare paid $2 million to resolve allegations it defrauded Medicare in billing for...

• DOJ recovers $9.3B in healthcare fraud

  The Department of Justice (DOJ) recovered at least $9.3 billion in healthcare fraud with help from...

Issue 35, September 1, 2008

• CMS issues guidance for innovators

  Innovators and healthcare providers can now find answers to questions about coverage, coding, and...

• FDA adds device to tracking list

  The FDA will require device manufacturers to track thoracic aortic aneurysm stent grafts, according...

• Stryker files suit against DOJ, OIG

  Stryker Corp. is suing the Department of Justice (DOJ) and Office of Inspector General (OIG) for...

Issue 34, August 25, 2008

• X Spine Systems cited for adulterated devices

  An FDA inspection found X Spine Systems, Inc., violated Good Manufacturing Practices and as a...

• Boston Scientific issues recall

  Boston Scientific voluntarily issued a Class I Recall of NexStent Monorail, NexStent Carotid Stent...

• States, NEJM editors against preemption

  More people are taking sides on the issue of preemption—whether pharmaceutical and medical...

• FDA issues final rule on label changes

  Pharmaceutical and medical device companies can amend the labeling for an approved product without...

Issue 33, August 18, 2008

• FDA toughens conflict-of-interest rules for advisory board members

  Outside specialists cannot participate in FDA advisory panels if they have a personal financial...

• Massachusetts governor explains intent of disclosure law

  Although some life sciences companies are concerned that Massachusetts’ new gift restrictions...

• Senators introduce anti-preemption bill

  Senators Edward Kennedy (D-MA) and Patrick Leahy (D-VT) introduced a bill designed to overturn the...

• J&J under investigation for bile duct stent marketing

  Johnson & Johnson (J&J) became the latest company to reveal that the Department of Justice...

• Device companies accused of paying kickbacks

  Five medical device manufacturers are facing more allegations they paid kickbacks to physicians...

Issue 32, August 11, 2008

• FDA releases guidance on qualifications for small businesses

  Small business can pay substantially smaller user fees for medical devices, but before a business...

• FDA releases 2009 medical device user fees

  Medical device companies will pay $200,725 for pre-market submissions to the FDA for fiscal year...

Issue 31, August 4, 2008

• Zimmer voluntarily suspends sale of artificial joint

  Zimmer suspended marketing and distribution of the Durom® Acetabular Component (Durom Cup) in...

• Abbott under investigation for stent sales, marketing

  The Department of Justice (DOJ) is investigating Abbott Laboratories’ sales and marketing...

Issue 30, July 28, 2008

• Survey

  Your feedback is the most important tool we have. Please help us meet your needs by completing a...

• CMS provides DMEPOS competitive bidding update

  Now that the Durable Medical Equipment, Prosthetics, Orthotics and Supplies competitive bidding...

• FDA issues guidance on pre-market approval applications

  Four different types of action by the FDA can affect the agency’s review time for pre-market...

• Device company settles with FDA

  Advanced Bionics LLC will pay $1.1 million to resolve allegations it failed to notify the FDA it...

Issue 29, July 21, 2008

• CT scans can interfere with medical devices

  Computed tomography (CT) scanning can lead to malfunction in implanted and external medical...

• FDA warns of dangers of rhBMP

  An FDA Public Health Notification warns of life-threatening conditions associated with recombinant...

• Competitive bidding stalled

  Congress overturned a presidential veto to enact the Medicare Improvements for Patients and...

Issue 28, July 14, 2008

• OIG testimony addresses Medicare and DME abuses

  Medicare paid questionable claims for durable medical equipment, prosthetics, orthotics, and...

• Physician Fee Schedule rule proposes reimbursement changes for devices

  Last week’s issue of Device Regulation Alert covered CMS’s proposals for cost sharing...

Issue 27, July 7, 2008

• Proposed changes to Physician Fee Schedule affect devices

  CMS’s proposed changes for the 2009 Physician Fee Schedule will affect the device industry.

Issue 26, June 30, 2008

• FDA wants more funding

  The Department of Health and Human Services asked Congress to provide the FDA with $275 million...

• House votes to delay DMEPOS competitive bidding

  The House of Representatives voted 355-59 Tuesday to delay the implementation of the Durable...

• ODE issues annual report

  The Office of Device Evaluation (ODE) detailed new developments in patient care and medical device...

Issue 25, June 23, 2008

• OIG reports on enforcement initiatives

  The Office of Inspector General (OIG) recovered $2.2 billion in healthcare fraud in the first half...

• CMS provides more information about DMEPOS competitive bidding

  CMS will send letters and brochure explaining the Durable Medical Equipment, Prosthetic, and...

• FDA eliminates baseline reports

  An FDA direct final rule will eliminate the need to prepare and file baseline reports regarding...

Issue 24, June 16, 2008

• Final guidance issued for tissue adhesive used to close skin incisions

  Beginning June 30, a device used to close surgical and laparoscopic incisions and simple traumatic...

• FDA offers draft guidance on angioplasty catheters

  The FDA is reclassifying percutaneous transluminal coronary angioplasty catheters (PTCA) as Class...

Issue 23, June 9, 2008

• What to expect from x-ray device inspections

  Manufacturers of diagnostic x-ray systems must ensure their devices comply with the Electronic...

• Guidance on 510k submissions for full field digital Mammography systems

  New FDA guidance offers assistance in preparing pre-market notification submissions (510(k)) for...

• FBI reports on healthcare fraud

  The FBI recovered millions of dollars from healthcare fraud cases in fiscal year 2007. A total of...

Issue 22, June 1, 2008

• FDA Deputy Commissioner testifies before Congress on preemption

  In testimony before Congress, FDA Deputy Commissioner for Policy Randall Lutter supported the...

• FDA focuses on patient safety and quality of care

  The FDA is starting a new program, the “Sentinel Initiative,” to identify post-market...

Issue 21, May 26, 2008

• Guidance on CLIA categories affects testing devices

  The FDA has issued guidance on the FDA’s procedures for categorizing the complexity of in...

• CMS provides DMEPOS updates

  CMS issued a flurry of announcements concerning the competitive bidding program for Durable Medical...

Issue 20, May 19, 2008

• We need your help

  Are you looking for information about a compliance topic? What would you like to receive expert...

• FDA issues two guidance documents concerning hemodialysis devices

  In April, the FDA issued two guidance documents addressing FDA submissions for hemodialysis devices.

• OIG addresses self-disclosure protocol

  A new Open Letter from the OIG provides additional requirements for self-disclosure reports that...

Issue 19, May 12, 2008

• FDA offers advice on how to submit IDEs for artificial discs

  New guidance assists the device industry with IDE applications for total artificial disc devices...

• New alternative for latex gloves approved

  The FDA approved a new type of natural rubber latex. The product comes from a desert plant called...

• Medicare to cover artificial hearts in clinical trials setting

  On May 1, CMS issued a final National Coverage Determination that provides Medicare coverage for...

Issue 18, May 5, 2008

• FDA explains when device certifications aren't necessary

  Draft FDA guidance will help device companies, sponsors, and FDA staff understand the obligation to...

• CMS releases addition information on DMEPOS competitive bidding project

  The April 21 issue of Device Regulation Alert discussed some new MLN Matters Articles addressing...

Issue 17, April 28, 2008

• CMS addresses device issues in proposed IPPS

  CMS has issued proposed changes to the hospital inpatient prospective payment system, including...

Issue 16, April 21, 2008

• Medical device regulation seminars offered

  The FDA and AdvaMed’s Medical Technology Learning Institute are offering seminars geared to...

• Educational articles available on DME competitive bidding

  Three new MedlearnMatters Articles explain how the DME competitive bidding program is being...

• FDA rejects proposed changes to Foreign Small Business Certification

  The FDA submitted an unchanged Foreign Small Business Qualification Certification, Form FDA 3602A...

Issue 15, April 14, 2008

• California device maker in trouble with FDA

  The FDA is seeking civil penalties exceeding $2 million from Advanced Bionics, LLC, a California...

• FDA drafts guidance on stents

  The FDA has proposed draft guidance for manufacturers regarding development of, and FDA submissions...

Issue 14, April 7, 2008

• CMS Expands Coverage for Continuous Positive Airway Pressure Devices

  CMS issued a final coverage policy affording coverage of continuous positive airway pressure (CPAP...

• FDA Releases Mammography Report

  On March 20, the FDA issued its Mammography Facility Adverse Event and Action Report, which is...

Issue 13, March 31, 2008

• DMEPOS competitive bidding contracts being finalized

  CMS predicts its competitive bidding project will save Medicare and its beneficiaries 26% on DME...

• FDA labels Medtronic letter to physicians a Class I Recall

  On March 21, the FDA posted a Class I Recall relating to a Medtronic letter to physicians...

• Claims of DME Fraud Lead to Jail Time

  Dallas and Florida DME suppliers and a California physician are heading to jail for charges...

Issue 12, March 24, 2008

• FDA goes to China

  The FDA plans to place eight staff members in China to expand its efforts to ensure safety of...

• FDA updates public health notification on graft systems

  For the third time this decade, the FDA has issued a public health notification about the need to...

Issue 11, March 17, 2008

• Senate hears testimony on relationships between device industry and physicians

  OIG Assistant Inspector General for Legal Affairs Gregory E. Demske detailed the risks associated...

• FDA proposed reclassifying medical device data systems

  The FDA wants to reclassify medical device data systems (MDDS) from a Class III device requiring...

• OIG issues new report on DMEPOS violations in LA County

  Following up on prior reports of DMEPOS abuses, the OIG has issued a new report that focuses on...

Issue 10, March 10, 2008

• FDA recommends alternatives to sterility testing

  The FDA is recommending alternative methods for sterility testing of medical devices, biological...

• Guidance for expediting premarket submissions updated

  Updated guidance on expedited review for premarket submissions for medical devices explains the...

Issue 9, March 3, 2008

• FDA proposes draft guidance on literature regarding unapproved uses

  The FDA released new draft guidance addressing industry distribution of articles discussing...

• FDA offers tips for premarket submissions for coronary and carotid embolic protection devices

  New FDA guidance issued February 15 provides device manufactures with advice on preparing premarket...

Issue 8, February 25, 2008

• Supreme Court rules in favor of device makers

  The Supreme Court handed down some good news for medical device makers on Wednesday when it ruled...

• FDA Drafts Guidance on Tests for Flu Viruses

  Device manufacturers now have more direction on how to gauge the performance of in vitro diagnostic...

• Sharing Savings OK with OIG, Part II

  The February 18 issue of Device Regulation Alert detailed two arrangements that involved physicians...

• How to Conduct a Medicare Coverage Analysis Overview Device Studies

  CMS' updates to its Clinical Trials Research Policy mean big changes to which services Medicare...

Issue 7, February 18, 2008

• CMS Proposes Changes to DMEPOS Supplier Standards

  Interested parties have until March 25 to comment on new and revised enrollment standards Durable...

• OIG allows gainsharing arrangements involving surgical devices

  The OIG gave a green light to two arrangements in which physician groups agreed to help a hospital...

Issue 6, February 11, 2008

• Medicare to cover artificial heart in research studies

  Since 1986, Medicare has denied coverage for artificial hearts, but on February 1, it took a step...

• CMS changes modifiers used in clinical research studies

  Three modifiers for use in identifying clinical services in research studies are being discontinued...

Issue 5, February 4, 2008

• FDA issues guidance on PMA manufacturing information and operations

  Recent FDA guidance addresses how the agency reviews manufacturing information provided during...

• Year in Review: OIG's 2007 DME enforcement

  The Office of Inspector General (OIG) administrative and criminal enforcement actions during 2007...

Issue 4, January 28, 2008

• FDA seeks public comment on user fee form for small business

  The FDA is seeking public comments on its Form 3602A that foreign businesses need to complete to...

• FDA Guidance Addresses Bioresearch Monitoring Program

  On January 8, the FDA issued guidance addressing the bioresearch monitoring process for premarket...

Issue 3, January 21, 2008

• FDA releases guidance on Interactive Review of Device Applications

  The FDA has issued new guidance regarding an interactive approach to premarket submissions for...

• FDA warns about device fragments

  On January 15, the FDA issued a Public Health Notification warning providers that pieces of medical...

Issue 2, January 14, 2008

• FDA announces modifications to list of recognized standards

  In a December 19 Federal Register notice, the FDA published modifications to the list of FDA...

• FDA updates eMDR

  In December, the FDA provided an update on its Web site concerning electronic medical device...

• CMS offers update on competitive bidding for DME

  In a January 8 press release, CMS announced the expansion of the competitive bidding project for...

Issue 1, January 7, 2008

• FDA warns of deaths after radio frequency ablation for lung tumors

  The FDA issued a public health notification on December 11, 2007, alerting the public to deaths...

• FDA offers e-mail alert regarding Web site changes

  Device manufacturers and others interested in keeping up with FDA news and approvals can sign up...

• DMEPOS fee schedule updated

  Forty-two HCPCS codes were deleted and 32 new HCPCS codes were added to the 2008 DMEPOS fee...

• LabCorp receives FDA warning letter

  Laboratory Corporation of America (LabCorp) is illegally marketing a blood test to detect ovarian...

Issue 47, November 24, 2008

• Government investigating off-label use of Medtronic device

  The Department of Justice (DOJ) is looking into the off-label use of Medtronic’s Infuse Bone...

Issue 34, August 25, 2008

• FDA releases guidance for passive device safety with MR

  Manufacturers of passive implants should provide non-clinical testing information premarket...

• OIG: Medicare overstated fraud recoveries

  Medicare allegedly instructed outside auditors ignore government policies designed to accurately...

Issue 3, October 13, 2008

• McKesson accused of Medicare fraud

  McKesson, North America’s largest durable medical equipment (DME) supplier, defrauded...

• CMS cracks down on fraud in South Florida

  On October 6, CMS announced it will ramp up efforts to curb Medicare fraud and abuse. The agency...