Regulatory relief for gastroenterologists

AGA position: AGA seeks regulatory relief for gastroenterology practices to enhance patient care.


Physicians continue to be burdened with onerous regulations and requirements from Medicare and other payors that take time away from patient care, are costly to their practices, and often have no benefit to improving patient care and outcomes. AGA urges the Centers for Medicare & Medicaid Services (CMS), other payors and Congress to provide relief to physicians in the following areas.

Prior authorization

Physicians are subject to prior authorization from most payors. Prior authorization — a medical management tool used by payors to ensure appropriate patient care and control costs — is tremendously burdensome to physicians and physician practices, and often interrupts and/or delays delivery of patient care. 

The services subject to prior authorization vary by payor, but also by plan type within a given payor. With each payor having hundreds, and in some cases thousands, of plans, physicians and physician practices are forced to comply with an increasing and unmanageable number of prior authorization requirements. Additionally, most payor requirements are neither transparent nor easily accessible. AGA urges payors to standardize prior authorization requirements and criteria, and make them transparent and easily accessible. Payors should proactively work to reduce prior authorization requirements to minimize physician administrative burden. AGA also encourages CMS to require a standardized and streamlined prior authorization process by Medicare Advantage and Part D plans. Additionally, approved prior authorizations should be valid for a minimum of one year. 

Finally, prior authorization requests are not always reviewed by payor medical directors or other physicians employed by payors. Medical treatment decisions should not be made by non-physician medical staff. AGA urges payors, including CMS, to develop and implement processes that allow for true “peer-to-peer” dialogues. Gastroenterologists seeking prior authorization for prescription drug or biologic therapy on behalf of a patient should be routed to a physician specialist in the same or similar discipline with expertise in the given condition to discuss the request; not a general nurse, pharmacist or other allied health professional who is unfamiliar with the disease processes and care management.

Step therapy

Patients, including those with digestive diseases such as Crohn’s disease and ulcerative colitis, are often subject to step therapy policies, also known as “fail first,” which occur when an insurer requires patients to try and fail one or more lower-cost prescription drug or biologic therapies before covering the therapy originally prescribed by their health care provider. Step therapy may also require patients to try a certain class or classes of drugs or biologics before another may be used. These policies deny coverage for safe and effective medications simply because they cost more. Such policies fail to consider the unique needs of specific patients. This practice is burdensome for the physician and patient. In some instances, appeals of step therapy policies can take months to resolve putting patients at risk for poor health outcomes and jeopardizing the physician-patient relationship. Some physician practices have a full-time employee devoted to navigating this process for patients, but not all practices have the resources to devote to this administrative burden. AGA urges insurers to reduce the burden of step therapy on physicians and physician practice. One step may be to incorporate step therapy approval and override processes into their prior authorization forms and procedures. Consolidation of step therapy and prior authorization processes would help reduce the administrative burden that physicians and physician practices face.  

AGA supports H.R. 2077, Restoring the Patient’s Voice Act, legislation introduced by Reps. Brad Wenstrup, R-OH, and Raul Ruiz, D-CA, that would require certain health plans to provide a clear and timely appeals process when a patient has been subjected to step therapy. The bill would also provide physicians and patients with exceptions to step therapy in critical circumstances.

Stark reform 

When Congress passed the Medicare Access and CHIP Reauthorization Act (MACRA), it changed the way physicians would be paid under Medicare and sought to transition physicians to a more value-based payment system. Physicians were incentivized to develop physician-driven payment models to improve efficiency and patient outcomes. However, with the existing Stark self-referral laws that prohibit physicians from referring patients to an entity in which they have a financial interest, practices are unable to participate in many advanced alternative payment models. The Stark laws, which were enacted nearly 30 years ago, pose barriers to care coordination since they prohibit payment arrangements that consider volume or value of referrals or other business generated by the parties. These prohibitions stifle care delivery innovation by inhibiting practices from incentivizing their physicians to deliver patient care more efficiently, because the practices cannot use resources from designated health services in rewarding or penalizing adherence to new clinical care pathways.  

Congress recognized that the Stark laws were a barrier to new care delivery models when it authorized the Health and Human Services Secretary to waive the Stark self-referral and anti-kickback laws for accountable care organizations (ACOs). Physician-driven alternative payment models (APMs) also need to be given this exception to drive innovation in health care and to implement the MACRA law as Congress intended.

AGA supports S. 2051/H.R. 4206, the Medicare Care Coordination Improvement Act, which would provide CMS with the regulatory authority to create exceptions under the Stark law for APMs and to remove barriers in the current law to the development and operation of such arrangements. The legislation would allow CMS to waive the Stark laws for physicians seeking to develop and operate APMs like what Congress allowed for ACOs. AGA believes this legislation is necessary for many of the innovative payment models developed by gastroenterologists to be implemented in the Medicare program.

Reviewed: March 2018