Keeping pace with the ever-changing life sciences industry, Morrison Foerster stays on top of the trends and political, legal, and economic drivers to support striking the balance between innovative discovery and purposeful business planning to assure our clients continued success. MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.Learn more about our <a href="https://www.mofo.com/capabilities/life-sciences-healthcare" target="_self">Life Sciences practice</a>.<h2 dir="ltr">ABOUT MORRISON FOERSTER</h2>Morrison Foerster is a leading global law firm that transforms complexity into advantage for its clients. Our clients include some of the largest financial institutions, banks, consulting and accounting firms, and Fortune 100, technology, and life sciences companies. Highlighting the firm’s commitment to client service, leadership in market-changing deals and impact litigation, and values-based culture, Morrison Foerster has been repeatedly recognized as one of the top 10 firms on The American Lawyer’s A-List. Year after year, the firm receives significant recognition from Chambers and The Legal 500 across their various guides, including Global, USA, Asia‑Pacific, Europe, UK, Latin America, and FinTech Legal. Our lawyers passionately care about delivering legal excellence while living our values. Morrison Foerster has a long-standing commitment to creating a culture that respects and celebrates differences, while providing an inclusive environment. The firm has achieved Mansfield Certification Plus since 2018 as a result of successfully reaching at least 30 percent women, communities of color, and LGBTQ+ lawyer representation in a notable number of current leadership roles and committees. The firm also has a long history of commitment to the community and society through providing pro bono legal services, including litigating for civil rights and civil liberties, improving public education and fostering the wellbeing of children, advocating for veterans, promoting international human rights, enforcing the right to asylum, and safeguarding the environment.

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Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants. She represents clients ranging from large international pharmaceutical companies to midsized companies, startups, and universities.Meghan has filed numerous Patent Term Extension applications to secure additional term for her clients’ patents, which cover FDA-approved products. In addition, Meghan has extensive experience addressing complex obviousness-double patenting and subject matter eligibility issues impacting her clients’ patent portfolios. Meghan also represents clients in both investor-side and target-side due diligence, in deals from seed funding to initial public offerings.Prior to law school, Meghan attended graduate school at the University of California, Los Angeles, where she received a Ph.D. in biological chemistry based on her work on protein-protein and protein-DNA interactions at a molecular level. Meghan is the author of several scientific publications and has presented her research at international conferences.Meghan received her J.D. from the University of Southern California Law School and spent a year as a visiting student at Santa Clara University, where she focused on intellectual property.

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Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants.

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Wolfgang advises clients on contentious and non-contentious matters involving their most valuable intellectual property assets in life sciences, digital, and high-tech industries.His subjects of focus include research and development collaborations, complex licensing agreements, and other technology transactions, as well as know-how protection strategies, and employee invention law. He also has substantial experience in litigating patents, trademarks, and other intellectual property assets, often in a multijurisdictional context. In addition, Wolfgang and his team frequently clear trademarks and ad campaigns and prosecute trademark applications.Wolfgang is co-editor of our <a href="https://lifesciences.mofo.com/" dir="ltr" target="_blank">MoFo Life Sciences Blog</a>.Wolfgang is a partner of Morrison Foerster based in our German office in Berlin.<h4 dir="ltr">Representative Transactional Matters</h4><ul dir="ltr"><li>U.S.-based BioTech fund on various research collaborations and other transactions with German start-ups or research institutions.</li><li>Negotiate multimillion-euro strategic partnership between two AgTech leaders concerning the development and commercialization of pest-resistant transgenic traits.</li><li>Craft global multi-million collaboration regarding AI-powered robotic MaaS.</li><li>UK-based digital health company on product roll-out of RPM applications in Germany; coordinate international expansion.</li><li>Advise numerous German start-ups on their U.S. expansion.</li><li>Draft diverse global patent and know-how license agreements in the areas of AgTech and life sciences—including gene licensing and licensing of genome editing technologies (e.g., CRISPR)—and medical devices; draft correlating supply and distribution agreements.</li><li>Structure IP rights in connection with joint ventures and other M&A transactions, including the carve-out of a patent-heavy semiconductor business comprising nine jurisdictions into a German–U.S. joint venture.</li><li dir="ltr">Advise on government-funded, multi-partner R&D projects and/or R&D projects with academic institutions, as well as on employee invention law.</li></ul><h4 dir="ltr">Representative Contentious IP Matters</h4><ul dir="ltr"><li>Lead counsel in an international dispute between software companies on rights and obligations following termination of a multi-million licensing and distribution arrangement; coordinate local counsel.</li><li>Defend Japanese chip manufacturer in high-profile SEP-litigation; advise on global settlement arrangement.</li><li>Represent leading internet retailer in patent infringement and concurrent invalidity proceedings in the context of a multijurisdictional dispute concerning touch-screen technology.</li><li>Represent diverse pharmaceutical and life sciences companies in national and cross-border patent infringement proceedings and other technology-related disputes, including preliminary injunctions as well as pre‑trial discovery and inspection proceedings, concerning, inter alia, drug-coating technologies, toner cartridges, medicinal gases, transgenic plants, and vaccines.</li><li dir="ltr">Conduct trademark, copyright, and false advertising litigation, including, most notably, a high-profile trademark litigation for a German bank, and a nine-country cross-border trademark litigation involving a famous pharmaceutical brand.</li></ul>

Dr. Wolfgang Schönig berät Mandanten zum Schutz des geistigen Eigentums sowohl in streitigen als auch nichtstreitigen Angelegenheiten, mit einem besonderen Fokus auf die IP-rechtliche Beratung von Unternehmen aus den Bereichen Life Sciences, Digitalwirtschaft und High-Tech.Zu seinen Beratungsschwerpunkten gehören Forschungs- und Entwicklungskooperationen, komplexe Lizenzvertragsgestaltungen und andereTechnologie-Transaktionen, sowie Know-how-Schutz-Strategien und das Arbeitnehmererfinderrecht. Er verfügt zudem über umfangreiche Prozesserfahrung zur Durchsetzung von Patenten, Marken- und anderen IP-Rechten, häufig auch in einem grenzüberschreitenden Kontext. Darüber hinaus bewertet Dr. Wolfgang Schönig zusammen mit seinem Team regelmäßig die Rechtskonformität von Werbekampagnen, prüft die Verfügbarkeit von Marken und entwickelt entsprechende Anmeldestrategien.Dr. Wolfgang Schönig ist Co-Editor des Life Sciences Blogs von Morrison Foerster.Er hat seinen Doktortitel an der Heinrich-Heine-Universität Düsseldorf und seinen LL.M. an der Fordham School of Law in New York erworben, jeweils mit Schwerpunkt im gewerblichen Rechtsschutz. Seinen MBA-Abschluss erhielt er von der European University in Barcelona.Dr. Wolfgang Schönig ist Partner des deutschen Büros von Morrison Foerster in Berlin.<h4 dir="ltr">Repräsentative Transaktionen</h4><ul><li dir="ltr">BioTech-Fonds mit Sitz in den USA bei verschiedenen Forschungskooperationen und anderen Transaktionen mit deutschen Start-ups oder Forschungseinrichtungen</li><li dir="ltr">Verhandlung einer hochvolumigen strategischen Partnerschaft zwischen zwei Technologieführern im Bereich Crop Science betreffend der Entwicklung und Kommerzialisierung von bestimmten Resistenzen</li><li dir="ltr">Gestaltung einer globalen Multi-Millionen-Zusammenarbeit für KI-gestützte Roboter</li><li dir="ltr">Ein in Großbritannien ansässiges Unternehmen für digitale Gesundheit bei der Markteinführung von RPM-Anwendungen in Deutschland; Koordination der internationalen Expansion</li><li dir="ltr">Beratung zahlreicher deutscher Start-ups bei deren US-Expansion</li><li dir="ltr">Strukturierung und Verhandlung diverser Patent- und Know-How-Lizenzen in den Bereichen Ag Tech und Life Sciences – einschließlich Fragen zu genome editing wie CRISPR-Medizingeräte, sowie Gestaltung von Softwarelizenzverträgen und Erstellung korrespondierender Liefer- und Vertriebsvereinbarungen</li><li dir="ltr">Strukturierung von IP-Rechten im Zusammenhang mit Joint Ventures und anderen M&A-Transaktionen, darunter die Koordination eines neun Länder umfassenden IP Carve-Outs im Rahmen eines Halbleiter-JVs</li><li dir="ltr">Beratung zu staatlich geförderten Multi-Partner F&E-Projekten und/oder F&E-Projekten mit akademischen Einrichtungen sowie zum Arbeitnehmererfindungsrecht</li></ul><h4 dir="ltr">Repräsentative IP-Streitigkeiten</h4><ul><li dir="ltr">Lead Counsel in einem internationalen Rechtsstreit zwischen Softwareunternehmen über Rechte und Pflichten nach Beendigung einer millionenschweren Lizenz- und Vertriebsvereinbarung; Koordinierung der lokalen Anwälte</li><li dir="ltr">Verteidigung eines japanischen Chipherstellers in einem prominenten Streitfall bezüglich Standardessentieller Patente (SEP); Beratung zu einer globalen Vergleichsregelung</li><li dir="ltr">Verteidigung einer führenden Internetplattform gegen Ansprüche eines Patenttrolls wegen vermeintlicher Verletzung von Patent bezüglich Touchscreen-Technologie sowie korrespondierende US-Streitigkeiten</li><li dir="ltr">Vertretung von Pharma- und Life Science-Unternehmen in nationalen und grenzüberschreitenden Patentverletzungsverfahren und anderen technologiebezogenen Streitigkeiten, einschließlich einstweiliger Verfügungsverfahren und vorprozessualer Beweissicherungs- und Besichtigungsverfahren, unter anderem in Bezug auf Arzneimittelbeschichtungstechnologien, Tonerkartuschen, medizinische Gase, transgene Pflanzen und Impfstoffe</li></ul>

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Wolfgang Schönig is a partner of Morrison Foerster (International) LLP based in our German office in Berlin. His practice specialty is advising on IP aspects relative to transactions in, among others, the life sciences, AgTech and pharmaceuticals industry, as well as legal representation in IP disputes. Wolfgang is specialized in research and development collaborations, complex licensing agreements, technology acquisitions, know-how protection strategies, and employee invention law.

Wolfgang Schönig focuses his practice on IP aspects relative to transactions in the digital, telecoms, high tech, life sciences, and pharmaceuticals industry, as well as legal representation in IP disputes.

Wolfgang Schönig advises clients on IP aspects relating to transactions in, among others, the life sciences, AgTech and pharmaceuticals industry, as well as legal representation in IP disputes. His additional focus areas include research and development collaborations, complex licensing agreements, technology acquisitions, know-how protection strategies, and employee invention law.

Wolfgang Schönig

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This week, the U.S. Food & Drug Administration (FDA) issued two much anticipated guidances, each outlining how COVID-19 devices will be treated after the expiration of the COVID-19 public health emergency (PHE) declaration or termination of the COVID-19 Emergency Use Authorization (EUA) declarations: 1) <a href="https://www.fda.gov/media/155038/download" target="_blank">Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency</a> (the “Enforcement Policy Transition Guidance”) and 2) <a href="https://www.fda.gov/media/155039/download" target="_blank">Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)</a> (the “EUA Transition Guidance”), both dated March 27, 2023. These final guidance documents finalize the corresponding draft guidances issued on December 23, 2021, and both set out a 180-day transition period.Enforcement Policy Transition GuidanceThe 180-day transition period under the Enforcement Policy Transition Guidance will start on the “implementation date,” which will be May 11, 2023, unless the PHE declaration is renewed another time contrary to the <a href="https://www.whitehouse.gov/wp-content/uploads/2023/01/SAP-H.R.-382-H.J.-Res.-7.pdf" target="_blank">Administration’s current plan</a>. The Enforcement Policy Transition Guidance applies to devices that fall under 15 FDA COVID-19 enforcement policies, where FDA has indicated that it does not intend to object to certain modifications or distribution of certain devices in the following categories:<ol><li>remote digital pathology devices;</li><li>imaging systems;</li><li>non-invasive fetal and maternal monitoring devices;</li><li>telethermographic systems;</li><li>digital health devices for treating psychiatric disorders;</li><li>extracorporeal membrane oxygenation and cardiopulmonary bypass devices;</li><li>remote ophthalmic assessment and monitoring devices;</li><li>infusion pumps and accessories;</li><li>face shields, surgical masks, and respirators;</li><li>gowns, other apparel, and gloves;</li><li>sterilizers, disinfectant devices, and air purifiers;</li><li>ventilators and accessories and other respiratory devices;</li><li>FDA-cleared molecular influenza and RSV tests;</li><li>coagulation systems; and</li><li>viral transport media.</li></ol>These policies are all currently set to expire on November 7, 2023, which is 180 days after May 11, 2023.The Enforcement Policy Transition Guidance sets out three phases: Phase 1 (first 90 days after the implementation date—expected to be from May 11 to August 8, 2023); Phase 2 (the second 90 days after the implementation date—expected to be from August 9 to November 6, 2023); and Phase 3 (180 days after the implementation date—expected to begin on November 7, 2023). In the Enforcement Policy Transition Guidance, FDA provides phase‑by‑phase compliance guidance for manufacturers of a device that falls under any of the FDA COVID-19 enforcement policies mentioned above. It is important to note that some of the guidance applies to manufacturers regardless of whether they intend to continue distribution of the device after a certain phase. For example, manufacturers should send a notification of intent to FDA regardless of whether they intend to continue distribution of their device after Phase 2.EUA Transition GuidanceThe 180-day transition period under the EUA Transition Guidance, on the other hand, will start when the corresponding EUA declaration terminates (the “EUA termination date”). The EUA Transition Guidance applies to devices that are authorized under any of the EUA declarations related to COVID-19 such as the <a href="https://www.federalregister.gov/documents/2020/02/07/2020-02496/determination-of-public-health-emergency" target="_blank">EUA declaration for COVID-19 in vitro diagnostics</a> (the “EUA devices”). As FDA explains in the guidance, an EUA declaration is not dependent on the PHE declaration, which means that the 180-day transition period for the EUA devices may start well after the PHE declaration expires, that is, possibly well after May 11, 2023.The EUA Transition Guidance requests manufacturers of the EUA devices that FDA deems to be “reusable life-supporting or life-sustaining” to submit a letter of intent to FDA as soon as possible, regardless of their intent to continue distribution of the device after the EUA termination date. Note that this request is effective as of March 27, 2023, and manufacturers should not wait until the transition period or the EUA termination date to submit the intent letter. Section A of the guidance provides the details including the product codes relevant to this request and the information to include in the letter.The EUA Transition Guidance also provides recommendations and policies for manufacturers seeking a full marketing authorization for a device related to any of their EUA devices. The guidance indicates that FDA does not intend to object to continued distribution of the EUA device after the EUA termination date, if (i) the manufacturer submits a marketing submission for a candidate device that is the same as, derivative of, or next generation of the EUA device, (ii) FDA formally accepts the marketing submission before the EUA termination date, and (iii) FDA has not taken a final action on the marketing submission. Since FDA’s formal acceptance of the marketing submission could be delayed due to various reasons, including administrative incompleteness of the submission, manufacturers are advised to submit well before the EUA termination date.FlexibilitiesNotably, both guidance documents indicate FDA’s willingness to be flexible in certain areas. For example, the guidance documents indicate that real-world data from the actual use of the device during the COVID-19 pandemic may be included in the marketing submission. Both guidance documents also recommend manufacturers to engage with FDA early in the transition period to discuss extenuating circumstances such as an ongoing clinical study that makes it difficult to meet certain deadlines provided in the guidance. Further, both guidance documents acknowledge that there may be unique quality system compliance considerations for certain manufacturers and suggest requesting an exemption or variance from a device quality system requirement within the first 90 days of each transition period.Finalization of these guidances does not necessarily mean that the COVID-19 EUA declarations will be terminated soon or that FDA will soon cease accepting and reviewing new EUA requests. At the same time, however, it certainly gets us closer to such transitions. This is an important development, and manufacturers who have distributed devices under an EUA or under one of these enforcement discretion policies during the pandemic should seek the advice of counsel to ensure compliance with the transition.

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Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.

Brigid DeCoursey Bondoc

Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.

Brigid Bondoc

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FDA Issues Final Transition Guidances for COVID-19 Devices

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This week, the U.S. Food & Drug Administration (FDA) issued two much anticipated guidances, each outlining how COVID-19 devices will be treated after the expiration of the COVID-19 public health emergency (PHE) declaration or termination of the COVID-19 Emergency Use Authorization (EUA) declarations:

FDA Issues Final Transition Guidances for COVID-19 Devices

On Thursday, March 23, 2023, the Food and Drug Administration (FDA) <a href="https://www.federalregister.gov/documents/2023/03/24/2023-06066/framework-for-the-use-of-digital-health-technologies-in-drug-and-biological-product-development" target="_blank">announced</a> the publication of the “<a href="https://www.fda.gov/media/166396/download" target="_blank">Framework for the Use of Digital Health Technologies in Drug and Biological Product Development</a>” (Framework) by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The publication of this digital health technology (DHT) framework fulfills an FDA commitment under the seventh iteration of the Prescription Drug User Fee Act reauthorization (PDUFA VII).What Are DHTs?In the context of the Framework, DHTs are “systems that use computing platforms, connectivity, software, and/or sensors for health care and related uses.” This includes technologies intended for use as a medical product, in a medical product, or as an adjunct to other medical products (i.e., drugs, devices and biologics). DHTs can be in the form of hardware (e.g., sensors for recording of physiological and/or behavioral data), software (e.g., mobile phone, smart watch), or a combination of both hardware and software (e.g., continuous glucose monitoring device with sensor and mobile application). DHTs may be used to support more efficient drug development and uses include increasing decentralization of trial-related activities (e.g., promoting increased trial diversity and retention of study participants), facilitating direct collection of information from patients, and allowing for development of novel endpoints that can help paint a more detailed picture of how participants feel and function in their daily lives.The Framework describes the multifaceted approach FDA intends to use to address how DHTs can be used to support drug development and regulatory decision-making, including workshops and demonstration projects, stakeholder engagement, establishment of internal processes to support evaluation of DHTs for use in drug development, and publication of guidance documents. The Framework itself is “not a guidance document and does not propose or establish policies.”Some of the significant issues addressed in the framework include:DHT Steering Committee – FDA established the DHT Steering Committee to develop internal programs to build review capacity and expertise and to ensure consistent review policies for the use of DHTs in drug development. The Committee has overseen the design of the Framework, and consists of senior staff from CDER, CBER, and the Center for Devices and Radiological Health, as well as the Oncology Center of Excellence and the Office of Clinical Policy and Programs. Committee activities will include:<ul><li>Gathering information on the present state of DHTs</li><li>Making policy recommendations on the use and evaluation of DHT-based measurements in drug development</li><li>Overseeing and coordinating DHT-related drug development working groups</li><li>Engaging with external stakeholders on DHT-related issues in drug development</li></ul>Technical Expertise and Training – FDA will “build on its technical expertise and develop training within the human drugs and biological products programs to enhance internal knowledge regarding the use of DHTs in drug development.” Areas of focus include: verification and validation, use of a participant’s own DHT or general-purpose computing platform, upgrades and updates of DHTs in drug development, artificial intelligence and machine learning, and technical consultation of experts and staff training.Consistency of Evaluations Across Review Divisions – “A single DHT measurement may be used for studies of different diseases and different drugs.” Review divisions and centers in the FDA should have consistent approaches to the review and evaluation of submissions that contain DHT-related data, and the Steering Committee is tasked with facilitating consistent approaches.Statistical Considerations in the Analysis of DHT-Derived Data – The use of DHT-derived endpoints presents “unique statistical considerations” for FDA related to data quality, technical data specifications, provenance, techniques, and algorithms used for processing, summarizing, and analyzing DHT data, and treatment of missing data during its reviews. Existing and novel statistical methods of validation of DHT-derived data must be assessed, and FDA states it will “consider developing technical data specifications to facilitate submission of readily analyzable DHT-derived data supporting drug development.” IT Capabilities – FDA anticipates “new challenges” with the “ability to receive and analyze large DHT-generated datasets to support a regulatory decision.” FDA will enhance its IT capabilities to support the review of such, including development of internal systems to monitor trends in submissions containing DHT-related data and establishment of a secure cloud technology to enhance infrastructure and analytics. After establishing the cloud, FDA will pilot a secure, cloud-based mechanism to support submission and review of DHT-generated datasets.FDA Meetings with Sponsors – FDA engagement with sponsors regarding the use of DHTs may occur at different stages of drug development, including pre-submission meetings, pre-IND meetings, IND and NDA review meetings, and other meetings and communications.Drug Development Tool Qualification Program – “FDA has qualification programs that are intended to support the development of tools for use in assessing medical products and that provide another avenue for sponsors and other stakeholders to engage with the Agency.” DHT developers may choose to pursue qualification of DHTs as drug development tools for a specific use, and a qualified DHT may be relied upon in multiple clinical investigations to support premarket drug submissions where the context of use is the same without having to repeat studies to support qualification.Guidance – To facilitate the appropriate use of DHTs in drug development, FDA has published various draft guidances, including the following:<ul><li><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/digital-health-technologies-remote-data-acquisition-clinical-investigations" target="_blank">Digital Health Technologies for Remote Data Acquisition in Clinical Investigations</a> (Dec. 2021)</li><li><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-systems-electronic-records-and-electronic-signatures-clinical-investigations-questions" target="_blank">Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers</a> (Mar. 2023)</li></ul>FDA plans to develop additional guidance in identified areas of need informed by stakeholder engagement and plans to publish the following draft guidance in 2023:<ul><li>Decentralized Clinical Trials for Drugs, Biological Products, and Devices (planned for 2023)</li><li>Regulatory Considerations for Prescription Drug Use-Related Software (planned for publication by end of 2023)</li></ul>Public Meetings – By Q2 2023 FDA will convene the first of a series of five public meetings or workshops with key stakeholders to gather input on issues related to the use of DHTs in regulatory decision-making for drug and biological product development. The first meeting is March 28–29, 2023 on <a href="https://duke.is/pzkwx" target="_blank">Understanding Priorities for the Development of Digital Health Technologies to Support Clinical Trials for Drug Development and Review</a>. Other meetings will be designed to address the following topics:<ul><li>Identifying approaches to DHT verification and validation</li><li>Understanding DHT data processing and analysis to inform the need for novel analytical techniques</li><li>Addressing the regulatory acceptance of safety monitoring tools that utilize AI/ML-based algorithms for pharmacovigilance purposes</li><li>Understanding emerging issues</li></ul>Demonstration Projects – “FDA will identify at least 3 issue-focused demonstration projects to inform methodologies for efficient DHT evaluation in drug development.” These projects may involve engagement with researchers, patient groups, and other stakeholders and will cover key issues to inform regulatory policy development and provide regulatory advice.External Organizations – FDA has participated in several forums addressing the use of DHTs in drug development and will continue to engage with external organizations to facilitate meeting the objectives discussed above.<a href="https://www.regulations.gov/docket/FDA-2022-N-3319" target="_blank">Comments on the Framework</a> must be submitted by May 23, 2023. MoFo is continuously monitoring these developments. Please reach out to MoFo’s FDA + Healthcare Regulatory and Compliance practice for a more detailed analysis and discussion of the implications of these developments.

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FDA Publishes Digital Health Technology Framework

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On Thursday, March 23, 2023, the Food and Drug Administration (FDA) announced the publication of the “Framework for the Use of Digital Health Technologies in Drug and Biological Product Development” (Framework) by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). 

FDA Publishes Digital Health Technology Framework

The Inflation Reduction Act of 2022 requires drug companies to pay rebates to Medicare when prescription drug prices increase faster than the rate of inflation for certain drugs. This inflation rebate applies to Medicare Part B rebatable drugs, which are single-source drugs and biological products, beginning January 1, 2023. See our previous blog post discussing CMS guidance on the Medicare Prescription Drug Inflation Rebate Program <a href="https://lifesciences.mofo.com/topics/cms-releases-guidance-on-the-medicare-prescription-drug-inflation-rebate-program" target="_blank">here</a>.Under the Rebate Program, the beneficiary coinsurance rate will be 20% of the inflation-adjusted payment amount for rebatable drugs and biologics, which will be less than what the beneficiary would pay in coinsurance otherwise. On March 15, 2023, the Centers for Medicare & Medicaid Services (CMS) <a href="https://www.cms.gov/newsroom/press-releases/inflation-reduction-act-tamps-down-prescription-drug-price-increases-above-inflation" target="_blank">announced</a> 27 prescription Part B drugs which will have an adjusted coinsurance rate based on the inflation-adjusted payment amount. These adjusted coinsurance rates will apply for the time period of April 1 to June 30, 2023. You can find the list of the 27 prescription drugs <a href="https://www.cms.gov/files/document/reduced-coinsurance-part-b-rebatable-drugs-apr-1-june-30.pdf" target="_blank">here</a>.As information in the Average Sales Price (ASP) quarterly drug pricing files is updated, the price of Part B rebatable drugs with a coinsurance adjustment may vary over time. Starting on April 1, 2023, and for each quarter thereafter, CMS will specify whether a coinsurance adjustment applies to a Part B rebatable drug for a calendar quarter in the quarterly ASP public files on the CMS website. The ASP public files may be found <a href="https://www.cms.gov/medicare/medicare-fee-for-service-part-b-drugs/mcrpartbdrugavgsalesprice" target="_blank">here</a>.We will continue to provide updates on developments related to the programs being implemented under the Inflation Reduction Act, as regulatory guidance will continue to be issued at a fast pace during this first implementation year of both the Medicare drug Rebate Program and the price negotiation program.

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CMS Announces Part B Prescription Drugs with Lower Coinsurance Amounts for Q2 2023

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The Inflation Reduction Act of 2022 requires drug companies to pay rebates to Medicare when prescription drug prices increase faster than the rate of inflation for certain drugs.This inflation rebate applies to Medicare Part B rebatable drugs, which are single-source drugs and biological products, beginning January 1, 2023.See our previous blog post discussing CMS guidance on the Medicare Prescription Drug Inflation Rebate Program here.

CMS Announces Part B Prescription Drugs with Lower Coinsurance Amounts for Q2 2023

On March 20, 2023, the new transitional regime for medical devices in the EU and the EEA became effective when <a href="https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.L_.2023.080.01.0024.01.ENG&toc=OJ%3AL%3A2023%3A080%3ATOC" target="_blank">Regulation (EU) 2023/607</a> (the “Regulation”) was published in the Official Journal of the European Union. The Regulation provides for highly anticipated extensions of the transition periods under the <a href="https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745" target="_blank">EU Medical Device Regulation</a> (MDR) and certain related provisions under the <a href="https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746" target="_blank">EU In Vitro Diagnostic Medical Device Regulation</a> (IVDR).The key elements of the Regulation are:<ul><li>An extension of the validity of certificates (MDR),</li><li>An extension of the transition period (MDR), and</li><li>The removal of time restrictions for sales (the “sell-off” periods) (MDR and IVDR).</li></ul>The Regulation is based on the European Commission’s proposal released on January 6, 2023 (the “Proposal”), which was adopted by the European Parliament and the Council on February 16, 2023. This article provides a brief overview of the above-mentioned key elements of the Regulation. As the text of the Regulation has not changed from the Proposal during the legislative process, we refer to our <a href="https://lifesciences.mofo.com/topics/eu-mdr-and-ivdr-implementation-european-commission-publishes-full-proposal-for-amending-transitional-regime" target="_blank">recent article</a> for a more detailed analysis of the content of the Regulation. It should also be noted that the Regulation’s amendments to the IVDR are limited to the abolition of the sell-off period. The rest of the IVDR’s transitional regime remains untouched. We discussed the IVDR transitional periods in this <a href="https://lifesciences.mofo.com/topics/eu-in-vitro-diagnostic-regulation-entered-into-force--part-2-of-3.html" target="_blank">article</a>.Extension of the transition periodThe Regulation amends the transition periods provided for in Article 120 of the MDR. The extension is gradual and depends on the risk class of the device. The transition period is extended from May 26, 2024 to December 31, 2027 for higher risk devices (e.g., Class III and Class IIb implantable devices, except certain devices exempted by the MDR) and to December 31, 2028 for medium- and low-risk devices (e.g., other Class IIb devices, Class IIa devices, and Class I devices placed on the market in sterile condition or with a measuring function).To ensure that only safe devices are placed on the market, the extension of the transition periods requires that certain conditions must be met:<ol><li>The devices must continue to comply with the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AMDD);</li><li>There are no significant changes to the design and intended purpose;</li><li>The devices do not present an unacceptable risk to the health or safety of patients, users, or other persons, or to other aspects of the public health protection; and</li><li>By May 26, 2024 at the latest,</li></ol>Extension of the validity of certificatesThe validity of certificates previously issued under the MDD, which are valid on the date of application of the MDR (May 26, 2021) and have not been withdrawn by a notified body, will remain valid for the duration of the proposed extended transition period of the respective risk class applicable to the device as set out above, provided that the conditions above are met.However, the Regulation does not address the formalities of an extended certificate. It is therefore unclear at this stage whether a new certificate or an amended certificate will be issued in the event of an extension, or on what other basis manufacturers can demonstrate that an otherwise expired certificate is in fact still valid. Manufacturers should watch out for forthcoming Q&A guidance documents addressing this issue.Removal of the sell-off periodsThe sell-off date requirement does not appear in the MDR and the IVDR. Therefore, devices placed on the market before the respective end of the transition period can continue to be available on the market without a legal time restriction.ConclusionThe medical device industry and its stakeholders can breathe a sigh of relief. While it took some time for the European Commission and EU Member States to recognize that an extension of the transitional regime was imminent in order to avoid a European healthcare crisis and it was necessary to take action, the adoption of the proposal and its entry into force have been accomplished in an unexpectedly swift process.However, while the time extensions provided by the Regulation may seem comfortable, manufacturers should be aware that important deadlines are fast approaching. Under each scenario, an MDR-compliant quality management system must be implemented and a formal application filed with a notified body by May 26, 2024. Of course, it can be expected that there will be a massive run on notified bodies at the end of this period. Thus, manufacturers would be well advised to prepare and submit their applications as soon as possible. Watch this space for further updates on this and other EU regulatory issues.

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Counsel

Robert advises companies from the technology and life sciences sectors on a wide range of commercial, intellectual property (IP) and regulatory matters. His clients range from multinational corporations to startups and scaleups.

Robert Grohmann

Robert Grohmann is counsel at Morrison Foerster’s German office in Berlin. As a member of the technology transactions group, he focuses on advising domestic and foreign companies and startups in all areas of technology and IP law, including patent and software licensing, employee inventions law, as well as know-how protection. Moreover, Mr. Grohmann’s expertise encompasses the judicial and extra-judicial representation in matters of trademark law, design law, and competition law.

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Eu Mdr and Ivdr Implementation: New Transitional Regime Enters Into Force

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On March 20, 2023, the new transitional regime for medical devices in the EU and the EEA became effective when Regulation (EU) 2023/607 (the “Regulation”) was published in the Official Journal of the European Union. The Regulation provides for highly anticipated extensions of the transition periods under the EU Medical Device Regulation (MDR) and certain related provisions under the EU In Vitro Diagnostic Medical Device Regulation (IVDR).

Eu Mdr and Ivdr Implementation: New Transitional Regime Enters Into Force

In <a href="https://cafc.uscourts.gov/opinions-orders/22-1116.OPINION.2-13-2023_2079642.pdf" target="_blank">ChromaDex Inc. v. Elysium Health Inc.</a>,[1] the Federal Circuit found U.S. Patent No. 8,197,807 (the “’807 patent”), which is directed to a dietary supplement comprising an isolated vitamin, invalid for lack of subject matter eligibility under 35 U.S.C. § 101. ChromaDex, a dietary supplement company and licensee of the ’807 patent brought a patent infringement suit against Elysium. The district court initially found the ’807 patent invalid under 35 U.S.C. § 101 as directed to a natural product. The Federal Circuit affirmed the district court’s decision, concluding that the dietary supplement in the asserted claims was not markedly different from naturally occurring milk.The ’807 patent relates to nutritional supplements containing isolated nicotinamide riboside (NR), a form of naturally occurring vitamin B3 present in non-isolated form in cow’s milk and other products. Claim 1 of the ’807 patent recites:A composition comprising isolated nicotinamide riboside in combination with one or more of tryptophan, nicotinic acid, or nicotinamide, wherein said combination is in admixture with a carrier comprising a sugar, starch, cellulose, powdered tragacanth, malt, gelatin, talc, cocoa butter, suppository wax, oil, glycol, polyol, ester, agar, buffering agent, alginic acid, isotonic saline, Ringer's solution, ethyl alcohol, polyester, polycarbonate, or polyanhydride, wherein said composition is formulated for oral administration and increases NAD+ biosynthesis upon oral administration.Elysium argued that the claimed composition reads on naturally occurring milk, which comprises NR, tryptophan, and the sugar lactose, and that the only difference between the two is that the claims recite that the NR is “isolated.” ChromaDex responded that the claimed NR composition is different from the naturally occurring form because it contains a stable isolated form of NR, which is bioavailable, sufficiently pure, and at a higher concentration than the NR found in naturally occurring milk. According to ChromaDex, NR is found only in trace amounts in naturally occurring milk and is primarily bound to whey protein.The Federal Circuit rejected ChromaDex’s arguments and sided with Elysium. Specifically, the court found that naturally occurring milk inherently increases NAD+ biosynthesis via tryptophan, regardless of the trace amounts of NR, and that the claims did not recite that the isolated NR must be bioavailable. In view of the decision in Myriad,[2] simply isolating the NR was found to be insufficient for patent eligibility; the claimed composition was not markedly different from naturally occurring milk. The court also distinguished its previous decision in Natural Alternatives,[3] where it found claims to specific formulations including natural products were patent-eligible because the natural products were incorporated into a dosage form with a particular characteristic. In contrast, the claims in ChromaDex did not require any minimum quantity of NR and they did not connect the recited increase in NAD+ biosynthesis to the isolated NR.This case demonstrates the continued relevance of subject matter eligibility to pharmaceutical and food supplement claims. The decision reaffirms Myriad by asserting that the mere recitation of “isolated” is not sufficient to confer subject matter eligibility and highlights key considerations for drafting claims. For example, patent applicants should provide description of any advantages and improved properties of a formulation over its natural counterpart in the specification and draft claims that provide a connection between the modifications to the natural product and the improved function. Applicant should also consider composition or formulation claims that recite specific thresholds or amounts outside those found in nature to reduce the impact of subject-matter eligibility issues.[1] ChromaDex, Inc. v.Elysium Health, Inc., No. 2022-1116 (Fed. Cir. Feb. 13, 2023).[2] Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (Jun. 13, 2013)[3] Natural Alternatives International, Inc. v. Creative Compounds, LLC, 918 F.3d 1338 (Fed. Cir. Mar. 15, 2019).

Don’t Cry Over Spilled Milk: Federal Circuit Finds Milk Vitamin Patent Invalid

Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants. 

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Don’t Cry Over Spilled Milk: Federal Circuit Finds Milk Vitamin Patent Invalid

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InChromaDex Inc. v. Elysium Health Inc., [1] the Federal Circuit found U.S. Patent No. 8,197,807 (the “’807 patent”), which is directed to a dietary supplement comprising an isolated vitamin, invalid for lack of subject matter eligibility under 35 U.S.C. § 101. ChromaDex, a dietary supplement company and licensee of the ’807 patent brought a patent infringement suit against Elysium.

The proliferation of private investor-backed management of health care practices continues to draw <a href="https://www.fiercehealthcare.com/regulatory/ftc-doj-promise-heavier-scrutiny-pe-deals-healthcare" target="_blank">scrutiny</a> from regulators into the impact on patient care, health care costs, and access to services. State regulators play a key role in monitoring and challenging anticompetitive behavior at the local level but have varying degrees of authority across the country to review or approve health care consolidation transactions. There are a growing number of states that are proposing or enacting laws requiring regulatory review of health care transactions that will significantly reshape the health care investment landscape. States have typically limited review and approval of health care transactions to larger provider types, such as hospitals. Recently, however, some states have expanded statutory requirements for review of health care transactions to physician provider groups and even management service organizations. For example, Massachusetts, Nevada and Washington have all enacted laws that require notice of material changes for certain transactions involving physician practices and other entities. Recently, New York and California, two of the states that are most active in reviewing and enforcing the corporate practice of medicine prohibitions and the activities of physician entities, have taken more direct steps towards broadening the reach of state regulatory authority to cover a wide array of transactions and entities.   I.	New York State Department of Health ProposalOn February 1, 2023, Governor Kathy Hochul released the New York State Executive Budget (“State Budget”) for fiscal year 2023-24. Embedded within the executive budget is a <a href="https://assembly.state.ny.us/leg/?default_fld=&bn=A03007&Summary=Y&Text=Y" target="_blank">proposal</a> that would give the State Department of Health (DOH) new authority to review and approve certain “material transactions” involving physician practices and other “health care entities” taking place in the state (“Proposal”). If enacted, this bill would add a new Article 45-A to the New York Public Health Law and subject health care transactions involving private equity and investor-backed entities to review. In articulating the purpose of the Proposal, the Governor cited an increasing number of physician practices that are managed by investor-backed entities, noting that these entities have assumed characteristics associated with clinics, insurers, and diagnostic and treatment centers, but remain “largely unregulated by the state.”a. 	Definition of “Health Care Entity” and “Material Transaction”The Proposal defines a “health care entity” to include a management services organization or similar entity providing all or substantially all of the administrative or management services under contract with one or more physician practices, provider organizations, health insurance plans, or any other kind of facility, organization, or plan providing health care service. Additionally, a “material transaction” is broadly defined to include mergers, acquisitions or affiliations with a health care entity, as well as “an affiliation or contract formed between a health care entity and another person” and the “formation of an … [MSO] for the purpose of administering contracts with health plans, third-party administrators, pharmacy benefit managers, or health care providers.” 	b.	Review ProcessUnder the Proposal, the health care entities engaging in a material transaction must submit written notice of the transaction to DOH at least 30 days prior to the closing date. If DOH does not respond within the 30-day timeframe, the transaction will be deemed approved, but DOH may extend the 30-day period if “necessary to conduct a thorough examination and complete analysis” of the transaction. The Proposal authorizes DOH to hire independent third-party entities to assist in a review and to charge the cost of retaining such third-party entities to the applicant. Furthermore, DOH will publicly post all written notices received regarding proposed transactions and will request public comments on the transactions. In its review, DOH would be authorized to consider a variety of factors, such as the financial condition of the transaction parties, the character and competence of the parties, the source of funds for the transaction, and whether the benefits of the transaction outweigh the potential negative effects on cost, access, health equity, and health outcomes.  	c. 	Penalties for NoncomplianceThe Proposal would grant DOH the power to impose a civil penalty of up to $10,000 for each day that a transaction is out of compliance, which would presumably extend into perpetuity until and unless an application is filed. The Proposal would also enable DOH to pursue an injunction against the closing of a material transaction that has not been submitted for review to DOH.	d. 	Key TakeawaysThe Proposal expands the scope of DOH regulatory authority to a very broad range of “health care entities,” which includes purely administrative service organizations, such as MSOs. The approval and public comment process under the Proposal could severely impact the landscape of health care related transactions within the State of New York, especially given that the factors to be considered in approving such a transaction include highly subjective criteria, such as the “character and competence of the parties.” Investors and entities in the health care space should carefully follow the progress of the Proposal, which could significantly hinder new investments in health care companies if adopted.II.	California Office of Health Care AffordabilityOn June 30, 2022, California Governor Gavin Newsom signed SB-184 into law, which created a new Office of Health Care Affordability (OHCA) within the California Department of Health Care Access and Information. To “increase public transparency,” OHCA is granted authority to “[r]eview and evaluate consolidation, market power, and other market failures through cost and market impact reviews of mergers, acquisitions, or corporate affiliations involving health care service plans, health insurers, hospitals, physician organizations, pharmacy benefit managers, and other health care entities.” 	a. 	Definition of “Health Care Entity”The statute defines “health care entity” as a “payer, provider, or fully integrated delivery system,” including health care service plans, health insurers, hospitals, hospital systems, pharmacy benefit managers, certain physician organizations, other providers (e.g., clinical labs), and other payers. [1] Entities excluded from the definition of health care entity include dentists, pharmacies, drug manufacturers, DME suppliers, home health agencies, and emergency medical transportation service providers.	b. 	Transactions Subject to OHCA ReviewGenerally, transactions that involve a change in ownership, operations, or governance structure that (i) sell, transfer, lease, exchange, option, encumber, convey, or otherwise dispose of a material amount of a health care entity’s assets to one or more entities; or (ii) transfer control, responsibility, or governance of a material amount of the assets or operations of the health care entity to one or more entities will be subject to review. [2] 	c. 	Review ProcessThe cost and market impact review process requires transaction parties to notify OHCA at least 90 days prior to closing. Within 60 days after receipt of the notice, OHCA will either advise the notifying party that OHCA will conduct a cost and market impact review or provide a written waiver from the review. During the cost and market impact review process, OHCA will evaluate (i) changes in size or market share in a given service or geographic region, (ii) prices relative to other providers, (iii) quality, equity, access, and other factors in the public interest, and (iv) benefits of the transaction, such as improvements in access, quality, and efficiency. [3] The review process includes an investigation by OHCA, which may subpoena health care entities and other relevant market participants to submit data and documents. An agreement or transaction subject to a cost and market impact review may not proceed until 60 days after OHCA issues a final report. During this time, OHCA may refer the transaction to the attorney general for review, and the attorney general may pursue litigation to block the transaction or allow it to proceed subject to specified conditions, such as the implementation of monitoring or ongoing reporting requirements.The advance review of these health care transactions is slated to begin on April 1, 2024, and OHCA will begin accepting required transaction notices in January 2024. OHCA is expected to promulgate regulations to provide additional details on the types of transactions subject to review and qualifying factors.	d. 	Key TakeawaysAlthough the statute does not grant OHCA authority to block or challenge health care transactions, OHCA does have the ability to significantly delay transactions that fall under its purview, given that no transaction for which OHCA conducts a review may close for 60 days following its delivery of a final report. Similar to the New York Proposal, SB-184 covers a wide array of transactions, including those that involve, for instance, MSOs, to the extent the transaction would cause a change in responsibility for operations of a health care entity. Investors that use MSOs as the investment vehicle for health care entities should carefully navigate the new requirements and oversight imposed by SB-184, beginning in 2024, and follow the promulgation of regulations over the coming months, which will further clarify the scope and nature of the law.                                                                     ****If you have any questions about the current trends in regulatory oversight of the practice of medicine, please contact Wendy Chow or Rachel Park.[1] <a href="https://casetext.com/statute/california-codes/california-health-and-safety-code/division-107-health-care-access-and-information/part-2-health-policy-and-planning/chapter-26-health-care-affordability/article-1-general-provisions-and-definitions/section-1275002-definitions" target="_blank">CA Health and Safety Code § 127500.2(k)</a>.[2] <a href="https://casetext.com/statute/california-codes/california-health-and-safety-code/division-107-health-care-access-and-information/part-2-health-policy-and-planning/chapter-26-health-care-affordability/article-8-health-care-market-trends/section-127507-health-care-market-trends-role-of-ofice-applicability" target="_blank">CA Health and Safety Code § 127507(c)(2); CA Health and Safety Code §§ 127507(c)(1)(A)-(B).</a>[3] <a href="https://casetext.com/statute/california-codes/california-health-and-safety-code/division-107-health-care-access-and-information/part-2-health-policy-and-planning/chapter-26-health-care-affordability/article-8-health-care-market-trends/section-1275072-cost-and-market-impact-review" target="_blank">CA Health and Safety Code § 127507.2(a)(1).</a>

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States Extend Scope of Regulatory Oversight of Health Care Entities

States Extend Scope of Regulatory Oversight of Health Care Entities

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The proliferation of private investor-backed management of health care practices continues to draw scrutiny from regulators into the impact on patient care, health care costs, and access to services. State regulators play a key role in monitoring and challenging anticompetitive behavior at the local level but have varying degrees of authority across the country to review or approve health care consolidation transactions.

The Inflation Reduction Act of 2022 (IRA) was signed into law on August 16, 2022 and includes several provisions to lower prescription drug costs for Medicare beneficiaries and reduce drug spending by the federal government. One provision of the IRA requires drug manufacturers to pay a rebate to the federal government if prices for certain drugs and biologics covered under Medicare Part B and Part D increase faster than the rate of inflation (CPI-U). Price changes will be measured based on the average sales price for Part B drugs and the average manufacturer price for Part D drugs. If price increases exceed inflation, drug manufacturers will be required to pay the difference in a rebate to Medicare equal to the total number of units sold in Medicare multiplied by the amount by which a drug’s price in a given year exceeds the inflation-adjusted price. Manufacturers that fail to pay the required rebate amount will face a penalty of at least 125% of the original rebate amount.The Part D inflation rebate provisions took effect in October 2022, and the Part B inflation rebate provisions took effect in January 2023. CMS intends to send the first invoices to drug companies for the rebates beginning in 2025. Invoices for Part B inflation rebates for Medicare for calendar quarters in 2023 and 2024 will be issued by September 30, 2025, and invoices for Part D inflation rebates owed to Medicare for the 12-month periods beginning October 1, 2022 and October 1, 2023 will be issued by December 31, 2025. Please see a more detailed timeline in Figure 1 below.On Thursday, February 9, 2023, the Centers for Medicare & Medicaid Services (CMS) released its initial guidance for the Medicare <a href="https://www.cms.gov/files/document/medicare-part-b-inflation-rebate-program-initial-guidance.pdf" target="_blank">Part B</a> and <a href="https://www.cms.gov/files/document/medicare-part-d-inflation-rebate-program-initial-guidance.pdf" target="_blank">Part D</a> Prescription Drug Inflation Rebate Program outlining the process for collecting rebates for both Medicare Part B and Part D drugs in line with changes from the IRA.CMS is seeking public input on various topics, including, but not limited to, the following:<ul><li>Process to determine the number of drug units for Part B and Part D rebatable drugs</li><li>Process to identify and remove excluded 340B units</li><li>Processes to address reduction or waiver in rebates for certain Part B and Part D drugs in times of drug shortages and severe supply chain disruptions</li><li>Process to impose civil monetary penalties on manufacturers of Part D rebatable drugs that fail to pay rebates</li><li>Mechanisms to ensure the integrity of the inflation rebate determination process</li></ul>Comments may be submitted to <a href="mailto:IRARebateandNegotiation@cms.hhs.gov">IRARebateandNegotiation@cms.hhs.gov</a> with the subject line “Medicare Part D Inflation Rebate Comments” or “Medicare Part B Inflation Rebate Comments” by March 11, 2023.Key Dates for Implementation:<div data-reactroot=""><img src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/blt2bba44a0c9fe2cde/63fe5b738d9f9910878e60c5/230228-medicare-prescription-drug.png?format=auto&amp;quality=60" alt="Medicare Prescription Drug Inflation Rebate Program Initial Guidance"/></div>Figure 1: CMS Factsheet: Medicare Prescription Drug Inflation Rebate Program Initial Guidance

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CMS Releases Guidance on the Medicare Prescription Drug Inflation Rebate Program

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CMS Releases Guidance on the Medicare Prescription Drug Inflation Rebate Program