November 16, 2010
VIA ELECTRONIC SUBMISSION
U.S. Department of Health and Human Services
Centers for Medicare & Medicaid Services
Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, DC 20201
RE: Medicare, Medicaid, and Children’s Health Insurance Programs; Additional Screening Requirements, Application Fees, Temporary Enrollment Moratoria, Payment Suspensions and Compliance Plans for Providers and Suppliers [CMS-6028-P] RIN 0938-AQ20
The Association of Academic Health Centers (AAHC) is pleased to provide comments to the Department of Health and Human Services (HHS or the Department) and the Centers for Medicare & Medicaid Services (CMS) to inform upcoming rulemaking related to section 6401(a) of the Patient Protection and Affordable Care Act, requiring providers and suppliers to establish a compliance program as a condition of enrollment in Medicare, Medicaid, and CHIP. The AAHC, representing more than 100 academic health centers nationwide, is dedicated to improving the nation's health care system by mobilizing and enhancing the strengths and resources of the academic health center enterprise in health professions education, patient care, and research. The AAHC Forum on Regulation executive leadership group comprises chief compliance officers from academic health centers across the country. Members of that group have been instrumental in crafting these comments.
Incorporation of U.S. Federal Sentencing Guidelines into Academic Health Center Compliance Programs
Academic health centers have had compliance programs in place for the past ten to fifteen years, and have incorporated the seven elements of an effective compliance and ethics program, as described in the U.S. Federal Sentencing Guidelines Manual, into those programs. Given this long-standing history with compliance programs, the academic health center community is uniquely qualified to comment on future compliance plan requirements for all providers and suppliers enrolled in the Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP).
Our member institutions have appointed chief compliance officers and, in many cases, several full-time staff members dedicated to various aspects of compliance. Where the chief compliance officer sits in the institutional hierarchy varies from one institution to the next, but the position is considered by most, if not all, academic health center CEOs as a key advisor and member of the leadership team.
Education and Training
Compliance programs at academic health centers operate full-scale education and training programs designed to keep administrators, faculty, staff, students, and volunteers aware of their legal and regulatory obligations. However, this element has proven difficult for many academic health centers due to the size of their workforce; high turnover in some positions magnifying the number of people requiring training; the large number of laws and regulations governing health care, research, and education; and the complexity of the institutions themselves. Academic health centers comprise multiple schools, graduate training programs, research laboratories, and teaching hospitals. However, the business arrangements that hold these institutions together vary significantly. Some academic health centers maintain ownership of their hospitals while others do not. Some academic health centers maintain close ties with their academic campuses, while others are free-standing institutions. These factors all contribute to a situation where maintaining information on the training needs and actions of each and every employee is an overwhelming task. Few off-the-shelf products are available with the capabilities to automate all of the necessary education and training functions, and many institutions have found it difficult to manage the myriad aspects of education and training properly.
Monitoring and Evaluation
To identify instances of inappropriate conduct, our member institutions have anonymous complaint hotlines that are monitored by the institution’s chief compliance officer. Academic health centers also maintain rigorous internal auditing functions. Internal audit staff are often completely independent of all other offices and departments within the institution, and frequently report directly to the institution’s Board of Directors or Trustees. Routine audits are done regularly and are targeted towards the most common problem areas, such as the unauthorized access of the medical records of an employee’s family member(s) or high-profile patients; accuracy of physician documentation, coding, and hospital billing practices; and adherence to Medicare teaching physician regulations. Systems for responding to allegations received through the compliance hotlines or identified through auditing are in place.
While formal evaluation processes of the compliance program as a whole may not exist at every academic health center, our compliance programs are constantly evolving and adapting to new challenges, risks and opportunities. The academic spirit of ethical conduct and transparency motivate our compliance programs to continuously strive to improve their systems. Some of our member institutions do contract with outside entities to conduct periodic reviews of their compliance programs, but those reviews are costly and are not within reach for every institution at this point.
Benefits of the Seven Elements of an Effective Compliance Program
Academic health center compliance officers have found the seven elements of an effective compliance program in the U.S. Federal Sentencing Guidelines very useful. The placing of these elements in the Federal Sentencing Guidelines has given significant weight to the importance of maintaining an effective compliance program and been helpful in conveying that importance to the administration, faculty, staff, and students of academic health centers. Furthermore, the seven elements have served to guide the actions of a compliance program without being too prescriptive in the methods by which an organization achieves the goal of preventing, detecting and correcting inappropriate behavior and criminal conduct. The AAHC believes the seven elements are an appropriate basis for the core elements of the required compliance programs for Medicare, Medicaid, and CHIP enrollment.
Challenges of Implementing Compliance Plan Requirements for all Providers and Suppliers
In general, the AAHC believes it is important not to impose a one-size fits all approach on compliance plan requirements. Establishing and maintaining an effective compliance program that incorporates the seven elements in the U.S. Federal Sentencing Guidelines requires significant investment not just of finances but also of human resources. Compliance efforts often need to be organized separately across the institution because they deal with widely disparate subject matter, personnel, and materials. For example, on any given day compliance staff may deal with issues related to clinical trials requirements, conflict of interest monitoring and disclosure tracking, the Health Insurance Portability and Accountability Act (HIPAA), the Family Educational Rights and Privacy Act (FERPA), electronic security, and red flag rules, just to name a few. Our member institutions’ compliance budgets have expanded as the regulatory environment has become more complex. For instance, one of our member institutions has seen a more than five-fold increase in its compliance budget (as it relates to the total operating budget) over the past ten years.
Electronic Data and Evaluation of Programs
Of particular concern is the anticipation on the part of CMS that providers and suppliers will be able to evaluate the effectiveness of their compliance plans using electronic data. We anticipate several problems with this concept. Firstly, effective measures will need to be developed that can be applied across institutions and sectors. Despite our long-standing commitment to maintaining effective compliance plans, the academic health center community has struggled to identify consistently effective measures to evaluate compliance. The AAHC would like to work with CMS and HHS to develop these measures.
Institutions will also need a system that can pull the necessary electronic data in a form that can be analyzed, and people who can mine that data. Particularly in larger institutions like academic health centers that have multiple electronic systems performing different functions, having a system in place that can extract data from all of those disparate systems in a useable format is extremely expensive and labor-intensive.
The AAHC recommends that CMS employ an iterative process to implement compliance plan requirements over a period of several years. We suggest that CMS propose a phased-in approach, similar to the process established for providers to attain the “meaningful use” of electronic health records. Further, we suggest that prior to making a compliance plan a requirement for enrollment, an incentive process be put into place to encourage the gradual adoption of the different core elements.
Thank you for the opportunity to submit our comments. The AAHC would be pleased to work with HHS and CMS to provide any additional necessary feedback on any upcoming rules regarding compliance plan requirements. If you have any questions regarding our comments or require any additional information on academic health center issues, please feel free to contact me at 202-265-9600.
Steven Wartman, MD, PhD
President and CEO
Association of Academic Health Centers