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Crowell & Moring has issued its seventh-annual “Litigation Forecast 2019: What Corporate Counsel Need to Know for the Coming Year.” 

The health care section of the Forecast, DOJ: Putting Limits On Guidance,” outlines how The DOJ’s Brand Memo may give health care contractors a new avenue of defense in FCA litigation, but how it will be interpreted is still unclear.

There is also an interesting discussion of how companies and law firms are leveraging technology to improve their legal operations and litigation strategy in the cover story, “Welcome to Your New War Room: How Technology Is Finding Its Way into Litigation Case Strategy.” It features interviews with in-house counsel at Cisco, Humana, United Airlines, and Lex Machina and discusses how technology is streamlining the collection and analysis of information to aid “data-driven” decision making along the continuum of litigation.

Be sure to follow the conversation on social media with #LitigationForecast.


Crowell & Moring has issued its Litigation Forecast 2018: What Corporate Counsel Need to Know for the Coming Year.”

 The health care section of the Forecast, “FCA Enforcement: Different, But Still Here,” outlines how health care companies should expect continued enforcement of the False Claims Act, but with perhaps different emphasis on key areas such as drug pricing.

 The Forecast explores the important litigation trends and challenges that businesses may face in 2018, and it features an in-depth look at how data-driven innovation is driving new opportunities and risks for clients across industries.

 Be sure to follow the conversation on Twitter with #LitigationForecast.



Yesterday, our colleague Troy A. Barsky testified before the U.S. Senate Finance Committee led by Chairman Orrin Hatch (R-Utah) and provided recommendations for modernizing the Stark Law to regulate self-referrals without impeding the care coordination and value-based payment models promoted by health care reform legislation. Other witnesses before the Committee included Dr. Ronald A. Paulus, president and chief executive officer of Mission Health; and Peter Mancino, deputy general counsel of The Johns Hopkins Health System Corporation.

During his oral testimony, Barsky raised the following points and recommendations to the Senate Finance Committee:

  • That the Stark Law is affecting the health care industry because it has moved beyond the bounds of its original intent;
  • Because of the changing nature of the health care system, the Stark Law should be reformed to facilitate new alternative payment models; and
  • What Congress can do to reform the law while still protecting patients and the Medicare program, such as removing the compensation-based prohibitions in the Stark Law and granting the Centers of Medicare & Medicaid Services more authority to issue broad waivers for a wider variety of innovative health care and payment systems to limit the piecemeal waiver approach developing under the Affordable Care Act.

In addition, Barsky urged that reform of the Stark Law should focus on “[m]aking bright line rules that providers can follow and expanding CMS’s authority to provide guidance through advisory opinions will greatly assist provider.” Other options for reform also included implementing a lower penalty scheme for technical violations of the Stark Law, and lowering CMS’s heightened standard of “no program or patient abuse” for promulgating new regulatory exceptions to the general prohibition” against self-referrals.

The Committee members in attendance, representing both the Republican and Democratic Parties, largely responded positively to comments shared by all of the witnesses during the hearing and Chairman Hatch said that the Committee would move reform proposals forward in the remainder of the year.

Barsky’s full written testimony can be found here. His comments are also featured in Bloomberg BNA, Inside Health Policy, Law360, and MedTech Insight (subscriptions required).

Accenture and Crowell & Moring LLP are excited to host the “Fostering Innovative Digital Health Strategies” conference on June 23, 2016 at the Crowell & Moring Washington, DC office. This event will bridge the intersection of business, legal, and policy issues that innovative companies face in developing and integrating successful digital health tools and platforms. Panelists will discuss their experiences on how to navigate both the risks and opportunities involved in these new health care tools and strategies. Speakers to include: Jodi Daniel, Crowell & Moring; Kaveh Safavi, Accenture; Zane Burke, Cerner; Bakul Patel, FDA; Anna Shimanek, CVS Health; Paul Uhrig, Surescripts; Dr. Elizabeth Raitz-Cowboy, Aetna Life Insurance Company; Soph Sophocles, Biogen Idec Inc.; and many more.

Fostering Innovative Digital Health Strategies Conference

Lawyers, business advisors, and thought leaders from across the industry and government will share their perspectives and insights on:

  • Predicted trends and innovations in digital health and health care Internet of Things (IoT)
  • Cybersecurity and privacy for digital health tools and information
  • Business and legal considerations in establishing a successful digital health platform
  • Pending legislation and regulations that may impact core strategic and investment decisions to be made now by health care providers, health plans, and technology companies
  • New payment models and data sources for greater coordination and quality of care and improved cost-efficiency

Check for updates on Twitter using the hashtag #DHSC2016.

Click here for additional information and to register for the conference on June 23 in Washington, DC.

On May 6, 2016, CMS published the Medicaid managed care final rule in the Federal Register. The Final Rule overhauls Medicaid managed care for the first time in 14 years and tracks many of the industry-wide developments that followed enactment of the ACA. Given the breadth of the rule, Crowell & Moring is covering it in a series of client alerts and blog posts. Part I covers the Final Rule’s medical loss ratio and actuarial soundness provisions. Part II addresses CMS’s novel approach to using Medicaid funds to provide coverage for inpatient stays at institution for mental diseases. Part III covers network adequacy. Stay tuned for future updates.

8/5/16: Please click here for newly released updates.

Managed Care Lawsuit Watch is Crowell & Moring’s summary of key litigation affecting managed care. If you have questions or need assistance on managed care law matters, please contact any member of the Health Care Group. Cases in this issue include:

  • Helfrich v. Blue Cross & Blue Shield Ass’n
  • King v. CompPartners, Inc.
  • Unilab Corp. v. Angeles-IPA
  • Kaiser Found. Health Plan, Inc. v. Burwell
  • Smilow and Katz v. Anthem Life & Disability Ins. Co.
  • Aetna Life Ins. Co. v. Huntingdon Valley Surgery Ctr.
  • Baptist Hosp. of Miami, Inc. v. Humana Health Ins. Co. of Florida, Inc.
  • Rose v. Healthcomp, Inc.

Last week, Democrats and Republicans from both chambers introduced the Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act (S. 2484, H.R. 4442), which would improve health care quality and realize cost savings by eliminating current restrictions on telehealth and remote patient monitoring. Click here to read our detailed analysis of the CONNECT for Health Act.


Featured Industry: Health Care
Spotlight on Best Practices, Litigation, Antitrust, and Tax for Health Care Companies

Crowell & Moring LLP is pleased to release its “2016 Litigation & Regulatory Forecasts: What Corporate Counsel Need to Know for the Coming Year.” The reports examine the trends and developments that will impact health care companies and other corporations in the coming year—from the last year of the Obama administration to how corporate litigation strategy is transforming from the inside out. This year will bring remarkable change for companies, as market disruptions and the speed of innovation transform industries like never before, and the litigation and regulatory environments in which they operate are keeping pace.

Continue Reading Crowell & Moring’s 2016 Litigation & Regulatory Forecasts: What Corporate Counsel Need to Know for the Coming Year

On January 7, 2016, the HHS Office for Civil Rights released guidance on individuals’ right to access health information under the HIPAA Privacy Rule. The guidance clarifies areas of confusion and non-compliance by covered entities and business associates, particularly in light of the proliferation of electronic health records and electronic health information. Areas of emphasis include: the provision of protected health information (PHI) in electronic form and format, use of mail and email, eliminating barriers to access including inappropriate fees, and distinctions between the requirements of the HIPAA Privacy Rule and the CMS Electronic Health Records Incentive program. Covered entities should review their HIPAA compliance practices in light of this guidance, particularly to ensure compliance with the 2013 HIPAA modifications. Click here for a more detailed analysis of key takeaways from our client alert.


The recent appropriations law, which will fund the federal government through 2016, suspends three health care taxes enacted under the Affordable Care Act, continues to limit how the Centers for Medicare & Medicaid Services can fund the temporary risk corridors program for the exchanges, and refines Medicare and Medicaid payments and funding. Click here for a more detailed analysis of the appropriations law’s impact on the health care industry.