HHS OIG Issues Another Regulation On Eve of Inauguration

On January 11, 2017, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued a final rule explaining new policies for excluding individuals and entities from participation in federal health care programs.  The final rule reflects amendments to the agency’s exclusion authorities made by the Affordable Care Act in 2010 and the Medicare Modernization Act in 2003.

The new regulation follows the two final rules that the agency issued on December 6, 2016 with respect to the Anti-Kickback Statute and Civil Monetary Penalties and in the face of requests from House and Senate Republicans to refrain from issuing any new regulations in the final days of the Obama administration.

The final rule presents many notable changes to the exclusion regulations.  First, the OIG announced that exclusions will only apply to misconduct from the past ten years.  Thus, the OIG may not revoke billing privileges as punishment for all wrongdoing, no matter how old.  Through this change, the OIG responded to the strong opposition it received against an unlimited statute of limitations.  Commenters pointed out that failing to provide a set time limit would leave providers subject to exclusion long after the underlying violation was resolved.  By setting the ten-year period, the OIG also acknowledged the “courts’ historical favoring of an enumerated limitations period.”

The final rule also establishes an early reinstatement process for providers that were excluded after losing their health care licenses for reasons including lapses in professional competence, professional performance, or financial integrity.  Previously, these providers could not be reinstated until the lost license was restored.  Under the final rule, however, the providers may apply for early reinstatement if they obtain or are permitted to retain a healthcare license in another state or retain a different healthcare license in the same state, or if they do not have a valid healthcare license but can demonstrate that they would no longer pose a threat to federal healthcare programs.  While providers who apply for early reinstatement must overcome a presumption against reinstatement that applies to the first three years after the loss of licensure, the three-year period is down from five years as suggested in the proposed rule.

The OIG also increased the amount that federal healthcare programs would have to lose in order for the loss to be considered an aggravating factor in determining how long the exclusion should last.  While in the proposed rule, the OIG suggested that the loss to federal healthcare programs would have to be no more than $15,000 in order to become an aggravating factor, the final rule set the amount at $50,000 in several scenarios.  This change addressed comments stating that $15,000 was too small an amount to warrant more severe punishment.  The final rule also removed a mitigating factor relating to the availability of alternative healthcare services furnished by the excluded provider (i.e., the fact that the patient’s access to care would be significantly harmed by exclusion of the provider no longer serves as a mitigating factor).  The patient’s access to care will still be considered in determining whether exclusion is appropriate, but it will be an “all-or-nothing” factor, rather than one that reduces the duration of exclusion.

Finally, the rule allows the OIG to exclude individuals who hold ownership or control interests in excluded entities.  It also allows exclusion of anyone convicted of a crime in connection with obstruction of certain investigations or audits.

Due to the timing of the issuance of this final rule, its long-term impact under the new administration is yet to be determined.  For example, while the final rule establishes new policies for excluding individuals and entities from participation in federal health care programs, it also amends definitions to clarify that a person or entity has “furnished” an item or service when the person or entity submits a claim or requests or receives payment.  While the clarification was merely intended to address “situations in which payment is made by a Federal health care program without a traditional fee-for-service claim, i.e., where the program makes payments through some other mechanism,” it’s possible that the agency may cite the revised definitions to further broaden it exclusion authorities.

FDA Issues Guidance for Classification Pathways for New Accessory Types

Accessories to medical devices play an integral role for their parent medical devices, supporting or adding to the parent device’s functionality.  Accessories historically took the classification of the parent device, except in cases where the Food and Drug Administration (“FDA”) classified the accessory in its own right.    The 21st Century Cures Act, passed into law on December 13, 2016, directed FDA “to classify an accessory based on the intended use of the accessory, notwithstanding the classification of any other device with which such accessory is intended to be used.”  To this end, FDA published a Guidance Document, Medical Device Accessories – Describing Accessories and Classification Pathway for New Accessory Types, that describes how FDA intends to classify new accessory types.

Accessory Classification Policy

FDA will determine an accessory’s classification by applying the same risk and regulatory control-based criteria that it currently does for other medical devices, according to the Accessory Classification Policy outlined in the Guidance Document.  FDA considers an accessory’s risks to be those it presents when used with the corresponding parent device, when used as intended.  FDA asks two questions to assess the accessory’s risk.

Is the article an accessory?  To determine whether a product is an accessory, FDA examines whether the product is intended for use with one or more parent devices, and whether it is intended to support, supplement, and/or augment the performance of the parent device.    An accessory should be intended for use with one or more specific parent devices. Equipment such as an off-the-shelf computer monitor would not be an accessory unless it is specifically intended for use with a medical device.  Such products may not be independently classified if they are not accessories to medical devices.

What are the risks of the accessory when used as intended with the parent device(s) and what regulatory controls are necessary to provide a reasonable assurance of its safety and effectiveness?  To answer this question, FDA intends to evaluate the risks imposed by the accessory’s impact on the parent device and any unique risks of the accessory independent of the parent device.  Not all risks of the parent device are imputed to the accessory, and likewise, the accessory may pose a different set of risks that the parent device may mitigate.

Next Steps

FDA recommends new accessory type manufacturers to use the de novo classification process at Section 513(f)(2) of the Food, Drug, and Cosmetic Act to request classifications for the new types of accessories.  Accessories that are already classified by an existing classification regulation or that are the subject of an already-approved PMA or 510(k) are not new accessory types, and need not be reclassified at this point in time.  Appendix 1 in the Guidance Document includes the information that FDA recommends accompany the de novo request for a new type of accessory.

Court Rejects HHS’s Plea to Rescind Order to End Medicare Appeals Backlog

As reported last month, the US District Court for the District of Columbia issued an order in American Hospital Association v. Burwell for the US Department of Health and Human Services (HHS) to clear the enormous backlog of Medicare appeals at the administrative law judge (ALJ) level. US District Court Judge James E. Boasberg gave HHS a four-year runway to eliminate the backlog of almost one million appeals at the ALJ level.

HHS’s first move was to ask Judge Boasberg to reconsider and to rescind his order. HHS contended that “the decision to order scheduled reductions in the appeals backlog will force [HHS] to pay pending claims without regard to their merit ….” The court rejected this argument, as it had already been presented by HHS and considered by the court in reaching its order. The court stated that it “is not unsympathetic to [HHS’s] plight, nor does it take lightly the decision to intervene in an executive agency’s efforts to respond to a complex problem.” Nevertheless, the court concluded it was bound by the instructions of the DC Circuit in a prior appeal of the matter and concluded “that equitable grounds existed” for the court’s order “and that the reductions timetable was the most appropriate form of such relief.”

It remains to be seen whether HHS will appeal the court’s decision. If it does not, this will end the long-running controversy and start bringing long-overdue relief to providers. The possible raft of appeals being rapidly decided still presents many issues, not the least of which is the extent to which interest will be due upon underpayments determined in successful appeals.

If you would like to discuss any of the details or implications of this matter for your business, please speak to one of the individuals listed in this publication or your usual contact at the firm.

Still sending Faxes? Consider content before hitting “send”!

Last week, the Federal Communications Commission (the Commission) released an Order denying a Petition for Declaratory Ruling by Kohll’s Pharmacy & Homecare, Inc. (Kohll’s) originally filed on March 29, 2016, requesting the Commission to declare that certain faxes describing the health benefits of flu vaccinations did not constitute unsolicited advertising under the Telephone Consumer Protection Act (TCPA) and, therefore, sending them did not violate the TCPA.  The sending of unsolicited fax advertisements, which Kohll’s apparently did, is squarely within the conduct restricted by the TCPA.

The TCPA, 47 U.S.C. § 227, is a federal statute that was enacted in 1991 to address concerns relating to telemarketing/solicitation practices. Not surprisingly, the TCPA has become a hot-button issue for class-action lawyers across the country due to uncapped statutory damages ranging from $500 to $1,500 per violation (the top end being reserved for “willful” violations), as well as an increasingly expansive interpretation of the statute given by the Commission and some courts.

The TCPA generally prohibits, among other things, the sending of unsolicited fax advertisements. The TCPA defines unsolicited advertisement to mean “any material advertising the commercial availability or quality of any property, goods, or services which is transmitted to any person without that person’s prior express invitation or permission, in writing or otherwise.”

Kohll’s petition stemmed from a lawsuit alleging that it had sent unsolicited faxes to businesses advertising the availability of corporate flu shots by Kohll’s. In its petition, Kohll’s contended that the faxes did not promote the sale of any good or service but rather provided health information and were intended to promote wellness by encouraging people to avoid illness by getting vaccinated.  Alternatively, Kohll’s sought a declaratory ruling that the faxes were exempt from the TCPA on the same reasoning underlying the exceptions for healthcare-related calls subject to HIPAA.  Finally, Kohll’s argued that exempting healthcare related calls, but not faxes, would violate the First Amendment as an overly burdensome restriction on commercial speech without a rational basis.  All of Kohlls’ arguments were unsuccessful.

The Commission ultimately concluded that Kohlls’ faxes clearly constituted unsolicited advertisements for the primary purpose of selling flu shots.  In its analysis, the Commission focused on three (3) primary aspects of the faxes:

  1. The language used by Kohll’s in the faxes;
  2. The amount of space devoted to advertising versus the amount of space used for non-advertising information; and
  3. The primary purpose of the faxes.

The Kohll’s fax stated in bold, highlighted print, “Corporate Flu Shots” and “Only $16-$20 per vaccination,” which were considered key elements indicating their “commercial availability” pursuant to the Commission’s definition of “advertisement.” Further, the use of the word “only” as a modifier of the $16-$20 price range evidenced that the purpose of the fax was not just to convey neutral facts, but rather to encourage sales. The inclusion of price in the fax was strongly probative in determining the language was an “advertisement” because the primary purpose of including price will almost always be to convince the fax recipient that the price for the product or service is reasonable and that a purchase should be considered.

When considering the amount of space devoted to advertising versus the amount of space used for non-advertising information, the Commission noted that in the only section of the fax arguably containing non-advertising information, the fax mentions, in much smaller print, the economic harms of flu infections and the commercial advantages of purchasing vaccinations for the employees of a business. However, even that language was interpreted by the Commission as encouraging a purchase of Kohll’s vaccination service so as to avoid the negative effects of the flu.

If you are interested in ensuring that you are compliant with current TCPA regulations, or if you are facing TCPA class action litigation or other regulatory complaint, please contact Paul Besozzi, Ben Tarbell, John Wyand, or Robert Nauman.


EU Agrees on New Medical Device and IVD Regulation

An article authored by Healthcare principal John Wyand and associate Sarah Stec published in the November/December edition of the Food Drug Law Institute’s Update Magazine, looks at the impact of the EU’s regulations governing medical devices and in vitro diagnostic medical devices.

The regulations seek to fill the regulatory gaps uncovered as technology evolved faster than the current regulatory regime. The authors predicted that the regulations “will strengthen the rules for placing medical devices on the market, as well as tighten market surveillance and vigilance. The regulations establish requirements for quality management systems, clinical evaluations and gathering clinical data, with specific duties for all economic operators, including manufacturers and distributors.”

The article reprint appears courtesy of FDLI .

President Obama Signs 21st Century Cures Act Into Law

On December 13, 2016, President Barack Obama signed H.R. 34, the 21st Century Cures Act (the Act), into law. This sweeping healthcare law addresses the discovery, development and delivery of new drugs and medical treatments; it also includes substantial mental health reforms and assorted Medicare- and Medicaid-related provisions.

The law is a product of the bipartisan 21st Century Cures Initiative, spearheaded by US House of Representatives Committee on Energy and Commerce Chairman Fred Upton (R-MI) and Representative Diana DeGette (D-CO). The Initiative held various events and authored policy papers on topics such as innovating public health agencies, incorporating patient perspectives into the regulatory process, and improving medicine and medical product regulation. The House passed a first version of the bill in July 2015.

On the other side of the Capitol, US Senate Committee on Health, Education, Labor and Pensions (HELP) Chairman Lamar Alexander (R-TN) and Ranking Member Patty Murray (D-WA) worked diligently on medical innovation legislation this past year, holding hearings and favorably reporting several pieces of legislation. The majority of these bills, however, did not reach the Senate floor.

Prior to the November elections, Senate Majority Leader Mitch McConnell (R-KY) and House Speaker Paul Ryan (R-WI) signaled their commitment to passing this legislation during the lame duck session, and the Act is a product of post-election bipartisan and bicameral negotiations.

The Act, which totals over 300 pages, includes many provisions of interest to healthcare providers. Highlights regarding care delivery and Medicare reimbursement include:

  • EHR Interoperability: The Act addresses interoperability of electronic health records (EHRs) by creating a model framework to securely exchange health information between networks. The Act seeks to promote the exchange of information between patient registries and EHR systems and allows the US Department of Health and Human Services (HHS) Office of the Inspector General (OIG) to investigate information blocking claims and penalize practices interfering with the lawful sharing of medical information. (Secs. 4003-4005)
  • Telehealth: The Centers for Medicare & Medicaid Services (CMS) and the Medicare Payment Advisory Commission (MedPAC) are required to inform Congress on the current use and limitations of telehealth services in the US. The provision underscores the need for a long-term solution for coverage of telehealth services and stresses the importance of covering telehealth services for Medicare beneficiaries as if the services were received in an in-person office setting. (Sec. 4012)
  • Hospital Readmissions: CMS is required to implement a transitional risk adjustment methodology, based on a hospital’s proportion of dual-eligible beneficiary patients, when assessing hospital readmission penalties. (Sec. 15002)
  • Payment Updates: The annual reimbursement update of the Inpatient Prospective Payment System is reduced from an increase of 0.5% to 0.4588% in FY 2018. (Sec. 15005)
  • Long-Term Care Hospitals: Under rules that went into effect in July 2016, Long-Term Care Hospitals (LTCHs) receive a lower reimbursement rate if more than 25% of their total annual Medicare patient population came from a single inpatient acute care hospital. This legislation reinstates the previous 50% threshold through October 2017. (Sec. 15006)
    Certain nonprofit LTCHs specializing in the treatment of spinal cord and acquired brain injuries are exempted from the lower site-neutral reimbursement rate for FY 2018 and FY 2019. LTCHs treating specific types of severe wounds are also exempted from the lower site-neutral rate in FY 2018. (Secs. 15009-15010)
  • Hospital Outpatient Departments: Section 603 of the Bipartisan Budget Act of 2015 (BBA) effectively reduced Medicare compensation paid to new off-campus hospital outpatient departments (HOPDs) beginning January 1, 2017, by eliminating HOPD eligibility for compensation under Medicare’s Hospital Outpatient Prospective Payment System (OPPS). Notably, the BBA contained no exception for HOPDs under development at the time of its passage. The Act corrects this by providing that HOPDs that (i) are the subject of a binding written agreement for construction, with an outside related party effective prior to November 2, 2015; and (ii) submit a provider-based attestation within 60 days of the Act’s enactment, will be considered “Grandfathered” HOPDs, and will be eligible for compensation under the OPPS. The Act also contains certain exceptions for cancer hospitals. (Sec. 16001-16002)
  • Critical Access Hospitals: The Act exempts Medicare providers for calendar year 2016 from enforcing the supervision requirements, originally finalized by CMS in 2008, for services and supplies provided in critical access hospitals. It also directs MedPAC to report to Congress within one year on whether the supervision exemption has impacted access to care for Medicare beneficiaries. (Sec. 16004)

The Act includes cost offsets, determined after months of negotiations. The offsets include: a drawdown of the strategic petroleum reserve; reductions in funding available from the Affordable Care Act, including the Prevention and Public Health Fund and funding available to territories; limitations of federal Medicaid reimbursement to states for durable medical equipment, prosthetics, orthotics and supplies to Medicare reimbursement rates; elimination of federal Medicaid matching funds for prescription drugs used for cosmetic purposes or hair growth, unless medically necessary; increased oversight of termination of Medicaid providers; and measures to reduce Medicare spending, including provisions focusing on payments for infusion drugs and home infusion drug services, and contracting and fraud penalties. (Secs. 5001-5012)

If you would like to discuss the implications of the Act for your business, or would like more information on expected legislation in the 115th Congress, please speak to one of the authors or your firm contact.

DOJ Juggernaut Will Continue To Rack in $$$$

The Department of Justice (DOJ) announced this week that it collected another $4.7 billion during FY 2016 under the False Claims Act (FCA). This was the third largest haul in history, bringing total recoveries since FY 2009 up to $31.3 billion.

Although DOJ did not say it directly, there seems no end in sight to huge recoveries. The sleeping statistic is the number new matters initiated. Although given less prominence than the total of yearly collections, the number of new matters is the source of future recoveries because large verdicts or settlements often take years to achieve. That means part of this year’s recovery depended upon new matters filed in prior years. In that sense, the number of new matters takes on a kind of delayed fuse effect.

In its announcement, DOJ reported 702 qui tam matters were initiated in FY 2016 – an average of 13.5 every week. In addition, DOJ initiated 143 false claims investigations not based on qui tams — for a total of 845 new matters. Although only some actions produce a recovery, the sheer volume of new matters demonstrates the potential for future recoveries. This point becomes clearer when the number of number new matters is compared to prior years. The total of 845 in FY 2016 was the second highest in history, with FY 2013 taking first place at 856 new matters. Moreover, the qui tam total in 2016 is the third time in history that the number of qui tams has surpassed 700. Things certainly have come a long way from FY 1987 when only 30 qui tam matters were initiated.

All this means that compliance and vigilance against fraud remains crucial in the healthcare industry because, regardless of what happens to healthcare reform, aggressive enforcement against fraud will continue. After all, what stakeholder in the healthcare industry is in favor of fraud?

A couple of other points of interest from the announcement:

The majority of this year’s recovery, a total of $2.5 billion, came from the health care industry, including drug companies, medical device companies, hospitals, nursing homes, laboratories, and physicians. This was the seventh consecutive year of health care fraud recoveries exceeded $2 billion.

Consistent with the policy initiative announced in the Yates memorandum on individual accountability for corporate wrongdoing, DOJ announced the names of some individuals who were here held personally responsible for paying recoveries under the FCA and the amounts that they were required to pay.

In addition to federal recoveries, false claims actions often result in additional recoveries for states because of healthcare expenses paid under Medicaid.

Other areas of recovery under the FCA besides healthcare include the financial industry and government contracting.

Court Directs CMS to Clear Medicare Appeals Backlog

On December 6, 2016, the US District Court for the District of Columbia issued an order in American Hospital Association v. Burwell giving CMS a four-year runway to clear the enormous backlog of appeals at the administrative law judge (ALJ) level. The Medicare Act requires ALJs to hold a hearing and to render a decision within 90 days of a party’s filing of its appeal with the Office of Medicare Hearings and Appeals. However, CMS has been unable to comply with this statutory deadline, with a backlog of almost 1 million appeals at the ALJ level.

In his decision, US District Court Judge James E. Boasberg granted summary judgment for the American Hospital Association and required CMS to meet the following deadlines and mandatory percentage reductions:

  • A 30% reduction from the current backlog of cases pending at the ALJ level by December 31, 2017
  • A 60% reduction from the current backlog of cases pending at the ALJ level by December 31, 2018
  • A 90% reduction from the current backlog of cases pending at the ALJ level by December 31, 2019
  • A 100% reduction from the current backlog of cases pending at the ALJ level by December 31, 2020

The court also noted that if CMS fails to meet the above deadlines, claimants at the ALJ level may move for default judgment.

The DC court’s decision may put an end to a long-running controversy and should start bringing long-overdue relief to providers. All eyes are on CMS now as it proceeds with implementing the court’s order and providing status reports every 90 days. The possible raft of appeals being rapidly decided presents many issues, not the least of which is whether any interest penalties will be due under the Medicare Act.

CMS Releases Final Rule Implementing Site Neutral Payment Rule for Hospital Outpatient Departments

On November 1, CMS released final rules implementing Section 603 of the Bipartisan Balanced Budget Act of 2015 (the Final Rule).  Section 603 effectively reduces Medicare compensation paid to certain off-campus hospital outpatient departments (HOPDs) beginning January 1, 2017 by eliminating their eligibility for compensation under Medicare’s Hospital Outpatient Prospective Payment System (OPPS).  The Final Rule generally adopts most of the provisions contained in the proposed rule released earlier this year, with a few significant exceptions.  The Final Rule also includes an Interim Final Rule establishing a mechanism for HOPDs to continue to bill directly for services.

Some of the Final Rule’s significant provisions are as follows:

Grandfathered HOPDs –  Under the Final Rule, HOPDs that furnished and billed for covered services prior to November 2, 2015 (Grandfathered HOPDs) remain eligible for compensation under the OPPS after January 1, 2017 and are excepted from the “site neutral” payment limits implemented by Section 603.  The Final Rule clarifies that a HOPD which first provided covered services before November 2, 2015, but did not bill for such services until on or after November 2, 2015, will be considered a Grandfathered HOPD provided that the bills were submitted in accordance with timely filing limits.

Relocation of Grandfathered HOPDs – Relocating a Grandfathered HOPD will generally result in the loss of excepted status for the Grandfathered HOPD, precluding it from continuing to bill under the OPPS after the relocation.  However, the Final Rule  provides for limited exceptions to the prohibition for reasons such as natural disasters, seismic building code requirements, and safety issues.  Rather than provide clearly defined exceptions, the Final Rule provides that each claim for a relocation exception is to be evaluated on a case-by-case basis by the relevant CMS Regional Office.

Expansion of Services at Grandfathered HOPDs – CMS will not implement its proposed restriction on service line expansion at Grandfathered HOPDs, at least for the time being.  In the Proposed Rule, CMS discussed implementing a system of “clinical families” to determine whether new services provided at a Grandfathered HOPD would be eligible for reimbursement under the OPPS.  In the Final Rule, CMS did not finalize this provision, but cautioned that it will monitor service line growth at Grandfathered HOPDs, and may propose a limitation in the future, including limitations on increases in service volume.

Change of Ownership of a Grandfathered HOPD – The Final Rule adopts the Proposed Rule’s provisions regarding change of ownership (CHOW) transactions.  Specifically, a Grandfathered HOPD will retain its excepted status in a CHOW transaction only if (i) ownership in the main hospital location is also transferred to the new owner and (ii) the new owner accepts the hospital’s existing Medicare provider agreement under which the Grandfathered HOPD is paid.   A sale of the Grandfathered HOPD alone will result in the loss of the Grandfathered HOPD’s excepted status.

Payment for non-excepted items and services  – Under the Proposed Rule, CMS suggested that it would not have a system in place by 2017 for HOPDs to bill under the Medicare Physician Fee Schedule.  The Final Rule (through an Interim Final Rule) address this issue by implementing a payment system for HOPDs that will permit them to continue billing Medicare directly in 2017.  Under the Final Rule, non-excepted HOPDs will be able to bill for services directly, receiving payments at Medicare Physician Fee Schedule rates that are roughly half of the current OPPS rates for 2017.  CMS anticipates updating the rates for 2018, and will explore other payment methods for implementation in 2019.  Under this payment system, services provided at non-excepted HOPDs will continue to be reported on the hospital’s cost report, which should mitigate concerns regarding whether non-excepted HOPDs would still be considered “child sites” for 340B purposes.

Dedicated Emergency Departments  –  The Final Rule provides dedicated emergency departments a categorical exception from the site neutral payment limits implemented by Section 603.  All services provided at a dedicated emergency department, whether emergency or non-emergency, will continue to be eligible for payment under the OPPS.

HOPDs Under Development – The Final Rule does not contain any provision providing exceptions for HOPDs that were mid-build or under development (and thus not furnishing services) as of November 2, 2015.  Absent a legislative remedy, these HOPDs will not be eligible for reimbursement under the OPPS.

CMS is soliciting comments regarding the Final Rule concerning the payment system, limitations on increases service volume among Grandfathered HOPDs and other issues.  Parties interested in submitting comments to CMS regarding the Final Rule and Interim Final Rule  provisions have until December 31, 2016 to submit such comments for consideration.

FDA Working to Modernize Medical Device Reporting in Hospitals

Recent medical device adverse events prompted FDA to take a fresh look at the ways it collects data related to medical device adverse events from hospitals.  FDA examined some high-profile adverse events, such as the spread of uterine cancer from the use of morcellators and the spread of infections by contaminated duoendoscopes, and found it never received the corresponding adverse event reports from the hospitals themselves.  To this end, on October 24, FDA reported on its blog that it had issued 483s, or violations of FDA’s medical device regulations, to a number of hospitals after inspections in December 2015.  Additionally, on October 25, FDA announced it will hold a public workshop on the role of the hospital in reporting device-related adverse events in device surveillance.

Reporting Requirements

“User facilities” are required to report certain adverse events with respect to medical devices within ten days of becoming aware of the information.  Hospitals, ambulatory surgical facilities, and nursing homes are all considered to be “user facilities” according to the Food, Drug, and Cosmetic Act.  User facilities are also required to submit an annual summary of the adverse event reports it submitted to both the manufacturer and to FDA.

These requirements may be news to hospitals and other user facilities, as FDA reported that it had yet to enforce these provisions and accompanying regulations.  In addition, the Food and Drug Administration Modernization Act (FDAMA) requires that FDA replace the universal system to one that is limited to a subset of user facilities.  This requirement prompted the Medical Product Safety Network (MedSun) to be created.  There are currently about 300 hospitals that are voluntary reporters to MedSun.  Even with MedSun, however, FDA has yet to limit the requirement for universal reporting in regulation.

Public Workshop

Realizing that gathering more comprehensive surveillance data for medical devices would require a better approach for user facilities to report on adverse events, FDA will hold a public workshop on December 5, 2016.  The goal of this workshop is to foster dialogue between user facilities and FDA regarding the value, cost, and challenges of current hospital-based reporting and surveillance, and what the role of hospitals should and could be.  The topics for discussion at the public workshop include:

  • An overview of the role of hospitals and potential benefits from a national evaluation system;
  • The role of hospitals in evidence generation and how it fits within the national system;
  • Current hospital-based surveillance efforts including participation in registries, patient safety organizations, electronic health records-based surveillance projects, and other surveillance projects;
  • A review of the role of hospitals in medical device reporting activities and current challenges hospitals face in complying with these requirements;
  • An exploration of MedSun;
  • Future surveillance opportunities for hospitals in the national system, including use of non-traditional sources of hospital data and capabilities;
  • A review of the potential benefits to hospitals in the national system and UDI implementation to modernize hospital surveillance; and
  • A discussion of how all the stakeholders can work together to improve hospital-based medical device surveillance.

Registration for the workshop is free, and the deadline to register is November 28, 2016.  FDA is also soliciting electronic and written comments on all aspects of the workshop topics.  The deadline for submitting comments is January 6, 2017.  Comments should include Docket No. FDA-2016-N-1380.  Electronic comments may be submitted through regulations.gov, and written comments may be sent to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD  20852.