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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 50, December 17, 2007

• CMS article explains device credit policy

  CMS issued a December Medlearn Matters article regarding Medicare reimbursement for recalled or...

• FDA updates warning about bed system

  On December 4, the FDA issued an updated public health notification warning hospitals to stop using...

Issue 49, December 10, 2007

• CMS instructs DME suppliers to use EY modifier and their NPI

  Beginning in May 2008, DME suppliers will have to attach the EY modifier to claims for DMEPOS items...

• FDA reclassifies blood separator and issues special controls

  The FDA has reclassified automated blood cell separator device operating on a centrifugal...

Issue 48, December 3, 2007

• Tired? Need new tools to refresh your compliance program and your career? Tell us about it.

  HCPro Inc. wants to know what we can do to help you wake up your facility's compliance efforts.

• FDA addresses consensus standards

  In three documents, the FDA offers guidance on the use of consensus standards, which are used...

• FDA addresses consensus standards

  In three documents, the FDA offers guidance on the use of consensus standards, which are used...

Issue 47, November 26, 2007

• Company voluntarily recalls IVADs

  Citing potential pneumatic leaks, Thoratec Corporation issued a worldwide voluntary recall of...

• FDA improves advisory committee process

  The FDA announced various efforts to improve the FDA Advisory Committee in a November 15, 2007...

Issue 46, November 16, 2007

• CMS discusses reason for scrutiny of costs for recalled devices

  Previously we told you about CMS's focus on healthcare costs related to recalled and replacement...

• AdvaMed drafts principles for comparative effectiveness research

  Concerned about use of comparative effectiveness research concerning medical devices and drugs...

Issue 45, November 12, 2007

• Beware dangers of excessive liquid cleansers on equipment

  Manufacturers should instruct device purchasers and users on the appropriate methods to use when...

• External defibrillators voluntarily recalled

  The FDA and Welch Allyn announced the company's voluntary Class I recall of automatic external...

Issue 44, November 5, 2007

• Medtronic removes defibrillator leads from market

  The FDA issued a statement on October 15, 2007, recognizing Medtronic's decision to voluntarily...

• Industry seeks to sway Supreme Court on FDA role

  AdvaMed and the Medical Device Manufacturers Association are paying close attention to a pivotal...

Issue 43, October 29, 2007

• AdvaMed concerned about lab competitive billing

  AdvaMed has expressed concern about how a competitive bidding demonstration project for clinical...

• FDA offers guidance for remote medication systems

  The FDA's new special controls guidance provides manufacturers with information on the pre-market...

Issue 42, October 22, 2007

• Recent settlements show how companies can respond to investigations

  Editor's note: This is the second in a two-part series on the recent settlement between the federal...

• OIG addresses FDA oversight of clinical trials

  An OIG report concludes the FDA needs to improve how it identifies clinical trials and...

Issue 41, October 15, 2007

• FDA guidance targets biological indicators

  The FDA released guidance for premarket submissions of biological indicators (BI) that monitor...

• Recent settlements highlight government focus on financial arrangements

  The recent settlements by five companies that market hip and knee surgical implants emphasize how...

Issue 40, October 8, 2007

• OIG Work Plan highlights device issues

  The Office of Inspector General (OIG) highlighted some medical device-related issues in its...

• MDUFMA changes to user fees and small business qualification

  Last week President Bush signed the Food and Drug Administration Amendments Act of 2007, which...

Issue 39, October 1, 2007

• President signs FDA Amendments Act

  On September 27, President Bush signed "The Food and Drug Administration Amendments Act...

• FDA addresses ASRs

  The FDA is using a question and answer format to offer guidance to manufacturers of commercial...

Issue 38, September 24, 2007

• FDA extends comment period on guidance for diagnostic devices

  In our September 3 issue we told you about draft FDA guidance for device manufacturers who develop...

• FDA issues warning for marketing unapproved uses

  The FDA recently issued a warning to a company claiming that it marketed a device for a use for...

Issue 37, September 17, 2007

• Joint Commission introduces VAD certification program

  This month, The Joint Commission announced the launch of its certification program for hospitals...

• FDA addresses fecal occult blood diagnostic devices

  Device manufacturers have new guidance for 510k submissions for fecal occult blood (FOB) tests. The...

Issue 36, September 10, 2007

• Class I recall shows importance of quality control

  A device company's quality control processes helped it uncover "falsified repair, test, and...

• FDA issues guidance on post-approval studies

  The FDA can condition pre-market approval on post-approval studies to generate reports on the...

Issue 35, September 3, 2007

• FDA holds educational forum

  Small device businesses, entrepreneurs, and start-ups can gain knowledge about FDA requirements and...

• FDA drafts guidance for diagnostic devices

  Device manufacturers who develop In Vitro Diagnostic Multivariate Index Assays (IVDMIA) have some...

Issue 34, August 27, 2007

• FDA helps manufacturers inform physicians about ICD recalls

  Device manufacturers have some new guidance about what to tell doctors when they notify them of...

• FDA and DoD collaborate on safety

  The FDA and the Department of Defense will partner to enhance safety review of medical devices and...

Issue 33, August 20, 2007

• FDA addresses devices with antimicrobial agents

  FDA addresses devices with antimicrobial agents

• Still more focus on recalled and replaced devices

  Still more focus on recalled and replaced devices

Issue 32, August 13, 2007

• CMS continues to address costs of recalled and replaced devices

  CMS continues to address costs of recalled and replaced devices

• CMS focuses on DME fraud

  CMS focuses on DME fraud

Issue 31, August 3, 2007

• Follow-up on compliance training

  Follow-up on compliance training

Issue 30, July 30, 2007

• Deciding what issues to address when training reps

  Deciding what issues to address when training reps

Issue 29, July 23, 2007

• OIG challenges company's sales practices

  OIG challenges company's sales practices

• Part Two: Tips for Training Device Reps

  Part Two: Tips for Training Device Reps

Issue 28, July 16, 2007

• To safeguard your business, train device reps about compliance concerns

  The medical device industry faces unique legal challenges and compliance concerns. That's one...

Issue 27, July 9, 2007

• Guidance on intervertebral body fusion device

  Guidance on intervertebral body fusion device

• FDA deputy talks to House about MDUFMA and other legislation

  FDA deputy talks to House about MDUFMA and other legislation

• FDA deputy talks to House about MDUFMA and other legislation

  FDA deputy talks to House about MDUFMA and other legislation

Issue 26, July 2, 2007

• OIG takes back excessive charges rule

  OIG takes back excessive charges rule

• Shelhigh and FDA settle

  Shelhigh and FDA settle

Issue 25, June 25, 2007

• Reminder on DMEPOS bidding

  Reminder on DMEPOS bidding

• DMEPOS fee schedule update

  DMEPOS fee schedule update

• FDA seeks comment on adverse event pilot project

  FDA seeks comment on adverse event pilot project

Issue 24, June 18, 2007

• Bid for equipment contract becomes expensive for bidder

  Bid for equipment contract becomes expensive for bidder

• FDA seeks advice on risk communication

  FDA seeks advice on risk communication

• Bid for equipment contract becomes expensive for bidder

  Bid for equipment contract becomes expensive for bidder

Issue 23, June 11, 2007

• Medicare won't cover lumbar artificial disc replacements for 60+ patients

  Medicare won't cover lumbar artificial disc replacements for 60+ patients

• FDA focuses on flu tests

  FDA focuses on flu tests

Issue 22, June 4, 2007

• New labor monitoring devices must meet guidance specs

  Any company submitting pre-market notification for a computerized labor monitoring system must...

• Factors that demonstrate financially stable competitive bidders

  Any device supplier who wants to bid in the Medicare DMEPOS Competitive Bidding Program must submit...

Issue 21, May 28, 2007

• Special report: Hospitals and rep credentialing programs

  Across the country, vendor access, or "credentialing," programs are restricting medical device and...

Issue 20, May 21, 2007

• The Scooter Store to pay $4M to settle False Claims Act allegations

  Wheelchair supplier The Scooter Store will pay $4 million to resolve allegations that it violated...

• Focus on manufacturing practices and sterility issues

  FDA scrutiny of your manufacturing practices can hurt your bottom line and bring some bad PR.

Issue 19, May 14, 2007

• Off-label uses of drug-eluting stents is common

  About half of drug-eluting stents used between 2004 and 2005 were used for off-label purposes...

• CMS proposes changes to IPPS reducing payment for replacement devices

  Reduced payment to hospitals for replacement devices are among CMS' recently proposed changes to...

Issue 18, May 7, 2007

• CMS sets new facility criteria for Ventricular Assist Device coverage

  Facilities seeking to implant ventricular assist devices (VADs) for destination therapy must now...

• CMS reverses plans to expand carotid stenting coverage

  In a blow to stent manufacturers, CMS reversed plans to expand Medicare coverage for using stents...

Issue 17, April 30, 2007

• Most physicians have industry ties, survey says

  A large majority--94%--of physicians reported some type of relationship with device...

• FDA lifts CRM warning against Boston Scientific

  The FDA has lifted a warning against Guidant after Boston Scientific, which acquired Guidant last...

Issue 16, April 23, 2007

• Former device execs charged with federal securities fraud

  Two former executives of the California-based device company Endocare have been indicted on federal...

• MDUFMA II calls for new fee structure, additional small business relief

  The FDA last week proposed reauthorizing the Medical Device User Fee and Modernization Act (MDUFMA...

Issue 15, April 16, 2007

• Certain equipment exempt from CMS' competitive bidding requirements

  Diabetes testing products are exempt from competitive bidding requirements, according to a CMS...

• Survey Series: Next steps for stakeholders to improve compliance

  A PricewaterhouseCoopers (PwC), King & Spaulding, and Compliance-Alliance survey of device...

Issue 14, April 9, 2007

• Survey Series: Challenges to implementing the AdvaMed Code

  Although a survey of device and diagnostics companies shows that nearly 100% have adopted the...

• Stent study not hurting insurance coverage

  Insurers don't seem to be swayed by a study that seemed to show that certain drugs provide...

Issue 13, April 2, 2007

• Survey Series: Effect of AdvaMed Code on device company operations

  According to a new survey of medical device and diagnostics companies, nearly 100% of companies...

• Device Congress: AdvaMed wants to calibrate Code with survey results

  review group is working on enhancements to the AdvaMed Code.

Issue 12, March 26, 2007

• Device, drug ties capped at $50K for docs on FDA ad boards

  The FDA has proposed stricter conflict of interest rules that set a grant or fee cap of $50,000 for...

• OIG: Hawaii, Virginia state false claims acts meet DRA incentive requirements

  The state False Claims Acts in Hawaii and Virginia meet all of the Deficit Reduction Act’s...

• Senate committee approves breast, cervical cancer diagnosis program

  A Senate committee approved this month the National Breast and Cervical Cancer Early Detection...

Issue 11, March 19, 2007

• Off-label use of bile-duct stents raises FDA ire

  The FDA and makers of bile-duct stents met last week to discuss concerns about off-label marketing.

• OIG to combine

  The OIG is in the process of combining its "Red Book" and "Orange Book" into one publication...

Issue 10, March 12, 2007

• Waxman requests marketing, research info from Boston Scientific, others

  Safety concerns and allegations of off-label use and inappropriate marketing are the focus of...

• Bill would update Medicare payments for diagnostic tests

  A new House bill aims to improve payments under the Medicare clinical laboratory fee schedule.