CMS Releases Instructions on PAMA Data Reporting

The Centers for Medicare & Medicaid Services (CMS) has now launched the new data reporting process for laboratories under the Protecting Access to Medicare Act (PAMA). Under CMS’s final PAMA rule, applicable laboratories must report private payor rates and other applicable information for certain clinical laboratory tests from a specified six-month data collection period. Additional technical information can be found on the CMS website, and in a slide presentation, available here. Continue Reading

Obama Administration Will Not Finalize LDT Framework Guidance

On November 18, 2016, the U.S. Food and Drug Administration (FDA or Agency) announced that it would not finalize the draft guidance entitled Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) (Draft Guidance) prior to the end of the Obama administration.

As we previously reported, FDA issued the Draft Guidance on October 3, 2014.  The document describes the Agency’s shift from enforcement discretion policy for LDTs to a risk-based framework under which LDTs would be regulated as medical devices pursuant to the Federal Food, Drug, and Cosmetic Act (FDCA).  In particular, the Draft Guidance outlined a phased-in approach for both premarket review and postmarket requirements, including registration and listing, medical device reporting, and Quality System Regulation (QSR) requirements.

Section 1143 of the Food and Drug Administration Safety and Innovation Act (FDASIA) required FDA to provide notification to Congress of its intent to finalize the Draft Guidance at least 60 days prior to the issuance of a final guidance. Although agency officials had stated that FDA would finalize the Draft Guidance by the end of 2016, the Agency had not provided this notification to Congress.  Had the Obama administration intended to move forward with a final guidance before the end of the administration, the notification required by FDASIA would had to have been issued by November 19, 2016.  At the same time, lawmakers had threatened to use the Congressional Review Act to block FDA from finalizing guidance documents imposing the FDCA on LDTs.

On Friday, an FDA spokesperson confirmed that the Agency would not finalize the Draft Guidance during the Obama administration:

“The FDA believes that patients and health care providers need accurate, reliable, and clinically valid tests to make good health care decisions — inaccurate or false test results can harm individual patients. We have been working to develop a new oversight policy for laboratory developed tests, one that balances patient protection with continued access and innovation, and realize just how important it is that we continue to work with stakeholders, our new Administration, and Congress to get our approach right. We plan to outline our view of an appropriate risk-based approach in the near future. It is our hope that such an approach will help guide continued discussions.”

We will continue to monitor legislative and regulatory developments relating to LDTs.

EU Medical Devices Regulation Series on Key Issues

It has been fairly quiet since the political agreement was reached last June on the EU Medical Devices Regulation (“the Regulation”). While the Commission’s lawyer-linguists iron out the final language, paving the way for formal adoption in the coming months, we are preparing a series of articles, beginning with this blog post, to address key aspects of the Regulation.

Comprised of around 100 provisions and extensive annexes, the Regulation contains dozens of topics that medical device professionals should be aware of. Our Medical Devices Regulation series will focus on select issues that we consider particularly noteworthy from a legal perspective. We would expect these issues to include the following topics:

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eHealth and mHealth Software Classification Changes in Forthcoming EU Medical Device Regulation

Phil Bradley-Schmieg and Alicia Payne

The new EU Medical Devices Regulation (MDR), a draft of which was tentatively agreed by the EU’s legislators on June 15, 2016, was revised at the last minute to include a new classification rule for software. Software’s classification under the MDR will determine its regulatory treatment (including what requirements it has to meet, and what regulatory approvals it must obtain).

The new rule is therefore relevant to companies and other organisations that sell clinical decision support or physiological monitoring software, including apps, that falls under the MDR’s reworked definitions of “medical device” or “accessory to a medical device.”

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CMDE Releases New Inquiry Rules on Medical Device Technical Review

On October 20, 2016, the Center for Medical Device Evaluation of China Food and Drug Administration (CMDE) released Guidance for the Management of Inquiry on Medical Device Technical Review (“New Guidance”).  The New Guidance replaces CMDE’s Guidance for the Management of Technical Inquiry on Registration of Medical Device (effective as of March 26, 2007, the “Prior Guidance”).   There are three major changes under the New Guidance: (i) The scope of these inquiries is narrower; (ii) In-person inquiries are limited to three times per application; and (iii) Two new inquiry channels were added—an online platform and “CMDE FAQs.” Continue Reading

FDA and CMS Permanently Establish Parallel Review

On October 24, 2016, the U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) published a notice in the Federal Register announcing the indefinite extension of the Parallel Review Program.  The agencies’ decision was based on “positive experience” from the Parallel Review Pilot Program, which has allowed manufacturers to conduct a single pivotal study to meet both agencies’ requirements and shorten the time to obtaining both FDA approval and a CMS national coverage determination (NCD).  As with the pilot program, the permanent program will accept no more than five candidates a year. Continue Reading

HHS Issues Guidance on HIPAA and Cloud Providers

The Department of Health and Human Services (HHS) recently published guidance on HIPAA requirements governing the use of cloud computing entities, specifically cloud services providers (CSPs).

In this guidance, HHS explains that CSPs that create, receive, maintain, or transmit protected health information (PHI) on behalf of a covered entity or business associate are considered business associates under HIPAA, and are therefore subject to HIPAA’s requirements.  HHS expressly rejects the idea that CSPs are analogous to “conduits” (such as internet service providers) that provide transmission-only services.  Rather, HHS explains that CSPs store and maintain PHI and thus have ongoing and routine access.

This guidance will be instructive to manufacturers of medical devices that connect to and store data on the cloud.

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District Court Dismisses State Law Unfair Competition Claim as Preempted by Federal Copyright and Patent Law

The Northern District of Texas recently held that federal copyright and patent laws preempted a state law unfair competition claim involving rival medical device companies.  The decision reflects that a preemption analysis does not consider whether the facts support actual protection by copyright or patent law.  Rather, the copyright preemption analysis looks to, among other things, whether the works “fall within the subject matter of copyright.”  The patent preemption analysis looks to whether the state law is used to protect “functional aspects” of a product.  Referencing Supreme Court jurisprudence, the decision reminds that “state regulation of intellectual property must yield where it clashes with the balance struck by Congress.”

A copy of the court decision is available here.  The decision is currently on appeal at the Fifth Circuit. Continue Reading

France Boosts Its eHealth Initiatives

The French Health Minister recently unveiled its 2020 eHealth National Strategy, with the intent to boost innovations through the use of big data in health.  The initiative is prompted by the advances in the ability to collect massive amounts of health data through connected devices such as phones, watches and apps, which present the opportunity to improve health monitoring, prevention and research.  In addition, according to past surveys, a vast majority of French people view eHealth initiatives as a promising tool for modernizing their healthcare system, but consider France to be lagging behind in this sector. Continue Reading

Industry Guidance on Unapproved or Off-Label Information Provides Insight Into Issues Under FDA Review

As we recently reported, in the wake of court rulings and settlements addressing the First Amendment in the context of providing truthful, non-misleading speech, including about unapproved (or, “off-label”) use of approved or cleared medical products, on September 1, 2016, the FDA issued a notice that it will hold a public hearing on November 9 and 10 concerning firms’ communications about such uses.  FDA’s notice also follows the release of a set of joint principles endorsed by the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO), known as Principles on Responsible Sharing of Truthful and Non-Misleading Information About Medicines with Health Care Professionals and Payers (“Principles”).  Although it is unclear whether or when FDA might provide guidance on its views regarding permissible truthful communications regarding off-label uses of approved or cleared medical products, statements and guidance from industry associations, such as the Principles proposed by and PhRMA and BIO, provide valuable insight to device manufacturers about the topics that are under review.  The industry statements may also assist the FDA in formulating new guidelines that take into account First Amendment principles outlined in recent court decisions and settlements. Continue Reading

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