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Marisa Adelson is an associate in Crowell & Moring's San Francisco office, where she practices in the Health Care and Antitrust groups. In her health care practice, Marisa represents managed care payors and provides counseling on regulatory compliance. Marisa's antitrust practice primarily involves complex antitrust recovery litigation. Marisa has an active pro bono practice and currently represents a client from South Asia seeking asylum in the United States.

In late June, Crowell & Moring partnered with Accenture to host a comprehensive one-day conference on legal issues affecting the digital health landscape. The program covered a wide range of topics, some of which you can read more about via the following links: Developing Digital Health Platforms; the Health Care Economy’s Internet of Things; and New Payment Models and Data. More information on the June 23rd “Fostering Innovative Digital Health Strategies Conference” can be found on Crowell.com.

One session touched upon privacy and cybersecurity issues regarding the usage of products and data in the digital health realm. This panel was moderated by Fauzia Zaman-Malik, Accenture’s Global Legal Lead for Health Industry Offerings and North America Legal Lead for Health and Public Services Operating Group; and featured Evan Wolff, partner at Crowell & Moring; Cora Han, FTC senior attorney, Division of Privacy and Identity Protection; and Hilary Weckstein, chief privacy officer at Inovalon, Inc.

This panel focused on methods and benefits of de-identification, HIPAA requirements, the FTC’s role in regulating big data and digital health technologies, and data breach preparation and response.  Keep reading for four key takeaways from this session; the full panel session can also be accessed by video at this link.


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On June 23, Crowell & Moring and Accenture co-hosted the Fostering Innovative Digital Health Strategies Conference in Crowell’s D.C. office. The goal of the conference was to take a comprehensive look at all of the business and legal issues that need to be addressed as health care organizations and technology companies are considering innovative strategies using digital health technologies. The conference covered a wide array of digital health topics, including trends in the healthcare Internet of Things, setting up digital health platforms, legislative activity regarding health IT and telehealth, privacy, cybersecurity, and use of digital health technology to support new payment models.

Session 2, “Setting up a Platform for Digital Health,” featured panelists Jodi Daniel (Partner, Crowell & Moring), Bakul Patel (Associate Director for Digital Health, Center for Devices and Radiological Health, FDA), Anna Shimanek (Senior Legal Counsel, CVS Health), Paul L. Uhrig (EVP, Chief Administrative, Legal, & Privacy Officer, Surescripts) and Ronan Wisdom (Managing Director, Accenture Digital).  Key takeaways include:

  • New partnerships are emerging. There is a broad movement among a variety of stakeholders – providers, payors, consumers, technology companies, and the government – toward using digital health to improve communicating with providers and patients’ understanding of their own health. This leads to new opportunities to partner with other organizations and require strategies for doing so effectively from a legal and business perspective.


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A key event in Congress affecting health information technology occurred last week when two members of the Senate HELP Committee issued a discussion draft of their bipartisan legislation on health information technology (health IT).  This ambitious bill addresses many of the same areas as other recent bills, including information blocking, transparency, a star rating system

On October 28, 2015, the U.S. Copyright Office of the Library of Congress (the “Office”) issued a Final Rule containing several exemptions to the Digital Millennium Copyright Act that expanded access to medical device computer programs and the patient data they generate.  The Digital Millennium Copyright Act allows intellectual property holders to install “technological protection measures” (TPMs) in their software which blocks unauthorized inspection of data to protect copyright.  Under the Act, the Library of Congress grants exemptions to TPMs every three years.

In the Final Rule, the Office included an exemption for researchers investigating computer programs on devices and machines for good faith security research. The Office found that legitimate security research has been hindered by TPMs that limit access.  Covered devices include medical devices used for patient implantation or corresponding personal monitoring systems, as long as they are not used by patients or for patient care.  The research exemption begins 12 months after the regulation’s effective date, meaning it starts on October 28, 2016.  Additionally, the Office created an exemption for patients who seek to passively access information that is already being generated by their own medical devices or personal monitoring systems.  Unlike the research exemption, the patient monitoring exemption takes effect immediately, and it is limited to patients themselves, as opposed to researchers or other parties.


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On December 17, 2014, the Centers for Medicare and Medicaid Services (CMS) published on its website a Frequently Asked Questions (FAQs) on its Quality Rating System (QRS) and Qualified Health Plan (QHP) Enrollee Experience Survey for QHPs on the insurance exchanges. Section 1311(c)(3) of the Affordable Care Act (ACA) requires CMS to develop a system

On November 26, 2014, the U.S. Department of Health and Human Services (HHS) released its proposed Notice of Benefit and Payment Parameters for 2016, also known as the “Payment Notice.” Now that HHS has completed the majority of its major rulemakings implementing the Affordable Care Act, the annual Payment Notice has become the recurring opportunity for HHS to modify Affordable Care Act (ACA) policy in a wide variety of subject areas. The 2016 Payment Notice touched on a number of policies, including essential health benefits (EHB), rate review, network adequacy and discriminatory benefit design, among others. Below is a summary of some of the key provisions of the 2016 Payment Notice.

Essential Health Benefits

Section 1302 of the ACA requires all non-grandfathered health plans in the individual and small group markets provide EHB to their beneficiaries. EHB are a comprehensive set of health care items and services. The Secretary of Health and Human Services defines the EHB to be covered; however, at a minimum, EHB must be equal in scope to the benefits covered by a typical employer plan and cover at least 10 general categories. The 2016 proposed Payment Notice would make several changes to the EHB regulations.
First, HHS proposes to establish a universal definition for one of these 10 general categories of care: habilitative services. Currently, issuers are required to match the habilitative services provided by the appropriate base-benchmark plan. When the base-benchmark plan does not offer habilitative services, the state in which the issuer is located may specify the services that are included in that category. If no definition is provided, however, the issuer is obligated to provide habilitative services benefits that are similar in scope, amount, and duration to benefits covered for rehabilitative services or to determine which services will be covered and report the determination to HHS. The proposed rule would alleviate this challenge for issuers by defining habilitative services as “health care services that help a person keep, learn, or improve skills and function for daily living.” Additionally, HHS proposes to remove the option for issuers to determine the scope of habilitative services under 45 C.F.R. § 156.110(c)(6).

Second, HHS wants to clarify that pediatric services should be provided until at least age 19. HHS proposes new language in 45 C.F.R. § 156.115(a) to clarify that coverage for pediatric services should be provided until at least the end of the plan year in which an enrollee turns 19.

Third, HHS proposes to give states the option of selecting a new 2014 plan to serve as their base-benchmark plan for the 2017 plan year. The proposed rule reinstates unintentionally deleted data submission requirements used to determine potential state benchmark plans.


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On October 15, 2014, the Centers for Medicare & Medicaid Services (“CMS”) launched a new accountable care organization (“ACO”) program that aims to encourage new Medicare Shared Savings Program (“MSSP”) ACOs in rural and underserved areas. The program, known as the ACO Investment Model, provides up to $114 million to as many as 75

On October 16, 2014, the Centers for Medicare & Medicaid Services (“CMS”) and the Office of the Inspector General (“OIG”) announced the continuation of the Accountable Care Organization (“ACO”) fraud and abuse waivers for an additional year. The Affordable Care Act (“ACA”) authorized creation of the Shared Savings Program to facilitate development of ACOs in

On July 16, 2014, the Consumer Information and Insurance Oversight (CCIIO) division of the Centers for Medicare & Medicaid Services (CMS) released an Enrollment Bulletin for the individual markets of Federally-facilitated Exchanges (FFEs) about grace periods for premium non-payment. The Bulletin addresses when grace periods related to terminations for premium non-payment fall across enrollment periods for the next benefit year. Issuers must provide a three-month grace period to Exchange enrollees who receive advance premium tax credits (APTCs), pay at least one month’s premium during the benefit year, and subsequently fail to pay their portion of the monthly premium. If the three-month grace period passes and the enrollee does not pay all outstanding premiums, the issuer must terminate the enrollee’s coverage, retroactive to the last day of the first month of the grace period. All other Exchange enrollees receive grace periods according to state law. The Bulletin explains the following for APTC recipients in FFEs:
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