Issue Brief Highlights New ACA Clinical Trial Coverage Requirements

Analysis Shows Importance of Case Management in Supporting Continuity of Care

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White Plains, NY, September 5, 2014—Alicare Medical Management (AMM), a national leader in care management solutions that promotes cost savings and client satisfaction, announces the publication of an issue brief titled “The Impact of the Affordable Care Act on Clinical Trials.” The issue brief provides important information about how the clinical trial coverage landscape is changing and useful insights for how health plan personnel, providers, case managers, benefit administrators, patients and others can proactively address these emerging issues.

“Clearly, clinical trials are essential to the advancement of medicine and the improvement of patient outcomes in countless areas of health care. Whether testing a new therapy or exploring a new way to use an existing therapy, clinical trials measure care and are responsible for landmark breakthroughs in science, as well as key information about treatment risks to different populations,” says David Walsh, President of Amalgamated Life Insurance Company and Chairman of Alicare Medical Management’s Board of Directors. “In this new issue brief, Alicare Medical Management details this important medical alternative, and includes information on how case managers can assist physicians and patients with navigating the process of enrolling in a clinical trial.”

The analysis addresses several key issues regarding clinical trial coverage and ensures the continuity of care for patients.  Among other findings, the issue brief highlights the importance of case management in providing guidance in situations where a patient is considering enrolling in a clinical trial. Sponsorship of clinical trials can come from federal agencies like the National Institutes of Health, pharmaceutical and device companies, or individual or hospital-based researchers.

“Clinical trials are performed to determine if new treatments and procedures, new drugs and combinations of drugs, or new devices are clinically safe and effective and should be used as a standard of care for future patients,” notes Claire Levitt, MS, AMM President. “Participation in clinical trials is often considered when standard therapies have failed. However, many practical questions and implications regarding clinical trials remain.  Understanding all of the key changes brought on by health care reform, along with the changing environment of clinical trial coverage and personalized medicine, means that physicians and patients must stay vigilant. This issue brief is a must read for anyone who wants to become more familiar with clinical trial coverage requirements.”


The issue brief includes a thorough discussion on several topics:

  • Part I: A Primer on Clinical Trials
  • Part II: The ACA Coverage Requirements
  • Part III: Paying for Clinical Trials
  • Part IV: The Role of Care Management in Clinical Trials
  • Part V: Appeals
  • Part VI:  Final Thoughts

In addition to each section, the issue brief includes two unique sidebars: a case study of the bone marrow clinical trial coverage in the 1990s, and a discussion of the emergence of personalized medicine, such as molecular profiling, in clinical trial coverage. These sidebars provide a fuller picture of the importance of clinical trials in today’s health care landscape. To view the issue brief, click here.

Julie O’Brien, RN, BSN MS, AMM senior vice president and COO, says, “Care management firms like Alicare Medical Management can use their utilization management, case management, and external review expertise to steer patients toward the best care options, address questions regarding medical necessity and scope of benefits, and act as an invaluable partner for anyone seeking guidance on their clinical trials coverage. We hope the publication of this issue brief clarifies any questions about clinical trials in a post-ACA environment.”

AMM provides its 24 hour Nurse HelpLine and its case management programs to health plans, insurers, hospitals, trust funds, employers, physician groups and government plans and is uniquely positioned to provide these services on a privately branded basis.  The 24 hour Nurse HelpLine Program can be a standalone program or can be fully integrated into AMM’s other care management offerings and can be customized to meet the needs of its clients.

For more information about AMM and its services, please contact Julie O’Brien at (800) 863-8688. To download a copy of the issue brief, click here.

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About Alicare Medical Management (

Alicare Medical Management (AMM), a member of the Amalgamated Family of Companies, is a national leader in developing care management solutions that promote cost savings and patient satisfaction. AMM’s call center is open 24 hours a day, 365 days a year to provide maximum access and assure optimum program effectiveness. The company’s services include: 24-hour Nurse HelpLine, Utilization Management, Maternity Management, Case Management, Disease Management, Health Coaching and Wellness, Independent Physician Review, Medical Claims Review and Hospital Bill Auditing. AMM holds four URAC accreditations for Utilization Management, Case Management, Health Call Center and Independent Review.

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