MDR Reporting Final Guidance

FDA issued a final guidance on November 8, 2016, “Medical Device Reporting for Manufacturers”.  As with all such guidance documents, it is nonbinding:  “It does not establish any rights for any person and is not binding on FDA or the public.”  Nevertheless, for those interested in medical device reporting, the document is required reading as it collects and refines Agency positions and expectations on everything from adverse event reporting basics, to definitions, to procedures and timing.

One item of potential utility to device manufacturers involved in product liability litigation is this Q & A:

3.4 When I submit an MDR report, is the report considered an admission that my device caused or contributed to the reported event?

No, the submission of a report or related information to us and our release of that information is not necessarily an admission that you, your employees, or your device caused or contributed to the reportable event [21 CFR 803.16].  We have included such a disclaimer on FDAs [sic] public database, [MAUDE] – Manufacturer and User Facility Device Experience.

This notion — that submission of an MDR is not an admission that the device actually caused the reported adverse event — is not new, but it is good to see it restated in this Final Guidance nonetheless.


CMS Finalizes Two-Track System to Implement Significant Changes in Medicare Physician Payment Policies Under MACRA

The Centers for Medicare & Medicaid Services (CMS) has finalized sweeping reforms of the Medicare physician fee schedule (MPFS) update framework, as mandated by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Beginning in 2017, physicians can choose one of two tracks within its “Quality Payment Program” to determine their MPFS update: reporting under the Merit-based Incentive Payment System (MIPS) or participation in an Advanced Alternative Payment Model (APM). A physician’s 2019 MPFS payment update (positive or negative) is based on action in 2017 – leaving little time to digest and prepare for the new framework before the system kicks in January 1, 2017. In order to give physicians and other affected clinicians additional flexibility going into 2017, CMS adopted several “transition” policies that will allow physicians to “pick their pace of participation” and report fewer quality measures, or report for a partial year and still avoid a negative payment adjustment in 2019, and possibly qualify for a positive adjustment.

While CMS transition policies are intended to help physicians avoid payment cuts in the first year of the program, these policies add to the complexity of the regulations. Read more about the major provisions of the final rule’s new payment framework and significant changes from the proposed rule in our Reed Smith Client Alert here.


Significant Changes for Long-Term Care Facilities Participating in Medicare and Medicaid Programs Issued by CMS

The Centers for Medicare & Medicaid Services (CMS) issued a final rule on September 28, 2016, comprehensively updating and extensively revising the requirements for participation (ROPs) for long-term care (LTC) facilities participating in the Medicare and Medicaid programs (the Final Rule). As the first major update to the requirements for LTC facilities in 25 years, the Final Rule will have a dramatic impact on LTC facility operations and finances. The Final Rule adopts numerous changes to the existing ROPs proposed in the July 16, 2015 proposed rule, and also includes various revisions to the proposed rule, in particular, modifications to the staffing and training requirements, care planning rules, infection prevention and control program provisions, and the prohibition on facilities’ use of pre-dispute arbitration agreements.

This discussion is not new here on the blog – we previously blogged about it here, as well as on our Health Industry Washington Watch blog. CMS reports that it received nearly 10,000 public comments on the proposed rule. In response to comments regarding the cost and resources required to achieve compliance with these significant new requirements, CMS will phase-in implementation in three phases.  Phase One, which includes many of the health and safety requirements, must be implemented by the effective date of the regulations, November 28, 2016.  Phase Two and Phase Three require compliance by one year and three years, respectively, from the effective date of the Final Rule (i.e., November 28, 2017 and November 28, 2019).

For more information on CMS’ Final Rule and the changes in requirements for LTC facilities participating in Medicare and Medicaid programs, read our full Client Alert here.

Philadelphia Life Sciences CLE Day for In-House Counsel: November 10

Reed Smith’s Life Sciences Health Industry Group is hosting a Life Sciences CLE Day at our Philadelphia office on Thursday, November 10. The day starts with breakfast and networking at 8:30 a.m. and sessions commence at 9 a.m. The event, which includes a working lunch, concludes at 2:30 p.m. This program is geared toward in-house counsel; space is limited.

Sessions include:

The CLE Day is presumptively approved for 6 CLE credits in New Jersey and 5 CLE credits in Pennsylvania. An application for Delaware credit is pending. For lawyers licensed in New York, this course is eligible for 6 credits under New York’s Approved Jurisdiction Policy. We hope to see you there!

For more information, or to register, please visit our website.

Please Join Us For Our Annual “12 Months in Health Care Law: A Roller Coaster Journey” Webinar

The Reed Smith Life Sciences Health Industry Group will be hosting an upcoming CLE webinar “12 Months in Health Care Law: A Roller Coaster Journey” on October 25, 2016 at 12:00 p.m. ET. Please join Reed Smith Partner Elizabeth Carder-Thompson as she presents her annual informative and entertaining review of many of the key regulatory developments and court rulings in health care law over the past 12 months. This fast-paced program will provide an engaging look at the twists and turns of our industry’s legal developments, including:

  • Record-breaking false claims act/whistleblower recoveries
  • Yates memo in action: arrests of corporate executives
  • Cases combining kickback, Stark, false claims theories
  • Regulatory developments: overpayments, physician payment changes, CMS innovation models, lab cuts under PAMA
  • Judicial pronouncements on off-label marketing
  • Continued health reform battles
  • Testing the government’s authority to extrapolate false claims
  • Escalating HIPAA settlements
  • Intriguing health care items you may have missed

This webinar is also approved for 1 hour of general CLE credit in CA, IL, NJ, PA, TX and WV. To register for the free webinar, please click here.

Join Us for a Free CLE Webinar on Social Media Issues for Pharmaceutical, Medical Device Companies

The Reed Smith Life Sciences Health Industry Group will be hosting a free CLE webinar, “Social Media Issues for Pharmaceutical and Medical Device Companies,” on November 2, 2016 at 12 p.m. ET. Social media can be a great way to engage with consumers and build your brand. For pharmaceutical and medical device companies, however, it can also open up a Pandora’s Box of regulatory issues.

In this webinar, Reed Smith presenters Celeste Letourneau, Kimberly Chow Sullivan, and Jennifer Pike will look at how drug and device companies can use FTC and FDA guidance to avoid these pitfalls. The presenters will address FTC and FDA regulations and cover recent warning or other enforcement actions, product liability considerations and current best practices.

This webinar is approved for 1 hour of general CLE credit in CA, IL, NJ, PA, TX and WV. To register for the free webinar, please click here.

Reed Smith Attorneys to Speak at DRI’s November 10th Government Enforcement and Corporate Compliance Seminar

Reed Smith attorneys Jason Casell and Steve Miller will be moderating and presenting respectively on the “Pharmaceutical and Medical Devices Industries Update” panel on November 10, 2016 at DRI’s Government Enforcement and Corporate Compliance Seminar.

This panel will examine recent government enforcement activities and legal decisions that might shape investigations, litigation, and resolutions of government claims. The criminalization of pharmaceutical and medical device FDA disclosure violations will also be addressed.

The DRI event will be held from November 10 to November 11 at the National Press Club, 529 14th Street, NW, 13th Floor Washington, DC 20045.

Other seminar sessions include:

  • The Foreign Corrupt Practices Act and Anti-Corruption Compliance
  • Data Breach: New Technology, New Challenges, New Risks
  • Health Care Fraud: Riding the Wave
  • Special Address: A Veteran’s Perspective on Key Principles of Professional and Personal Success
  • Anti-Money Laundering and Bank Secrecy Act
  • Special Address: Perspectives from a Federal Prosecutor
  • When the Client Is in the Crosshairs: Strategies for Responding to Government Investigations
  • Global Antitrust Enforcement
  • A False Claims Act Case Study
  • Environmental Dangers: Compliance and Ethics in Environmental Law

For full information on this informative DRI seminar or to register, please visit the event’s website. In-house counsel who are DRI members receive complimentary registration.

OIG Encourages CMS Claim Forms Which Will Allow For Better Tracking Of Implantable Medical Devices

On September 30, 2016, the Department of Health and Human Service’s Office of the Inspector General (OIG) issued an “Early Alert” to the Centers for Medicare & Medicaid Services (CMS) on “Incorporating Medical Device-Specific Information on Claim Forms”.  This Early Alert urges CMS to update Medicare claims forms to include the “device identifier” (DI) portion of the “Unique Device Identifier” for implantable medical devices, and to encourage providers to make proper use of an existing two-digit field for reporting “device failures and recalls.”

According to the Early Alert, OIG decided to make this recommendation after it conducted an audit into “the Medicare costs associated with seven cardiac devices from three manufacturers.”  Because OIG “could not determine from the claims data alone the specific device implanted and whether the device replacement was due to a recall, a premature failure, or a necessary upgrade,” it “had to establish complex audit procedures and undertake the labor-intensive process of obtaining and reviewing the device recipients’ medical records to identify” Medicare payments it believed were due to “recalls or premature device failures.”

OIG says that “the lack of medical device-specific information in the claims data impedes the ability of CMS to readily identify and effectively track Medicare’s total costs related to the replacement of recalled or defective devices” and that its recommendations will “assist in identifying the costs to Medicare for recalled or defective medical devices, help ensure patient safety, and safeguard Medicare trust funds.”

European Patent Litigation for Life Sciences Companies: a Silver Lining to the Brexit Cloud?

The introduction of the Unified Patent Court (UPC) is undoubtedly the most significant change to the European patent landscape since the European Patent Convention of 1973. It will have a profound effect on how life sciences companies set about their patent strategies – from filing through exploitation to enforcement.

Leaving aside the inevitable delays to the UPC project, there is a serious risk that Brexit means that the UPC will be diminished in the eyes of one of its major user constituencies, the international life sciences companies. These companies have extensive experience of the alternative to the UPC, the national country-by-country litigation route.

Counter intuitively, Brexit may make the UK a more important patent litigation venue than it would have been as part of the federal UPC system. The UK’s commercial significance means that companies will have to litigate in the UK as well as in Europe (whether in the UPC or in the national courts).

  • Brexit has, if anything, shifted the strategic balance. A diminished federal UPC system in Europe without UK participation runs the risk of being seen as less appealing by its potential users, especially the global life sciences and technology companies.
  • Brexit may increase the attractiveness of the current national litigation route as an alternative to the UPC for life sciences companies.
  • Brexit is likely to increase English patent judges’ willingness to grant pan-European declarations of non-infringement, paving the way for more complex and disruptive patent litigation strategies.

Please click here to read the full article drafted by London IP partner, Jonathan Radcliffe on this topic (originally published in August 2016 by Bloomberg).

Off-Label Promotion And The First Amendment Updates

Although activity around the Amarin and Pacira cases has settled down, questions regarding the FDA’s position on truthful off-label promotion-and whether it comports with First Amendment free speech principles—persist.

The FDA has announced a two-day public hearing on November 9 and 10, 2016 regarding “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.”  In-person attendance is via pre-registration, written comments are accepted via (and should reflect the docket number “FDA-2016-N-1149”), and the meeting will be webcast as well.

Even more recently, on September 19, 2016, the Medical Information Working Group (MIWG) filed an amicus brief on these issues with the District of Massachusetts in United States v. Facteau in support of the defendants’ motion for a judgment of acquittal or new trial.

As the MIWG brief explains:

In particular, the MIWG has sought to address concerns that the current enforcement scheme is at odds with fundamental First and Fifth Amendment principles that permit manufacturers to engage in truthful and non-misleading communications about off-label uses of their products.  The unclear rules that characterize the regulatory framework, and the Government’s expansive and ad-hoc approach to enforcement, provide inadequate notice of the line between permissible and impermissible speech and, as a result, manufacturers’ constitutionally protected speech is chilled.

Id. at 1.

This MIWG brief should be a useful resource for anyone addressing off-label promotion issues, regardless of whether those involve alleged regulatory violations (as with the criminal prosecution in Facteau) or allegations of tort liability in civil litigation.  And, it cites to our colleagues over at the Drug and Device Law Blog for their post about how long it has taken to get clarity from the FDA about the First Amendment free speech issues with its regulation of off-label promotion.