Georgia's Trusted Healthcare
& Medical Provider Attorneys

CMS Proposes 2 New Stark Exceptions

drIf adopted, the new exceptions will provide physicians with more options when setting up financial arrangements with hospitals.

On July 15, the Centers for Medicare & Medicaid Services (CMS) published several proposed changes to the Stark regulations as well as two new exceptions. The changes made pursuant to the proposed rule would clarify certain requirements which must be met for many of the Stark Law exceptions.

One notable change would impact several Stark exceptions (e.g., office space and equipment rental, personal service arrangements, physician recruitment arrangements, etc.) which require that an arrangement be either “in writing” or memorialized in a “written agreement.” If adopted, the proposal would make the writing requirement uniform throughout by replacing “written agreement” with “in writing.” CMS’s comments further clarify that a formal contract is not required. Rather, if under the circumstances it is appropriate, the writing requirement may be satisfied with a collection of “contemporaneous documents evidencing the course of conduct between the parties.”

CMS also provides clarification on how to satisfy Stark exception requirements that are conditioned on having an arrangement that lasts at least one year. According to CMS, a “formal contract or other document with an explicit ‘term’ provision is generally not necessary to satisfy the [one-year-term] element.” An arrangement that lasts at least one year satisfies the requirement.

The two new Stark Law exceptions involve payments related to employment of non-physician practitioners and timeshare arrangements for the use of office space, equipment, supplies, etc. The first exception would allow hospitals, Federally Qualified Health Centers and Rural Health Centers to subsidize physicians for the cost to employ physician assistants, nurse practitioners, clinical nurse specialists and certified nurse midwives up to a certain amount. The goal of the proposed exception is to promote the expansion of access to primary care services.

The other proposed exception would protect timeshare arrangements if certain requirements are met. Such arrangements would need to be between a hospital or physician organization (licensor) and a physician (licensee) for the use of the licensor’s premises, equipment, personnel, items, supplies, or services. Additionally, the licensed premises, equipment, personnel, items, supplies, and services would need to be used predominantly for evaluation and management services to patients of the physician.

If adopted, the new exceptions will provide physicians with more options when setting up financial arrangements with hospitals. However, CMS also clarifies and broadens certain limitations — the percentage of a hospital that may be owned by physicians will now encompass all physician owners, regardless of whether a physician owner refers patients to the hospital.

The CMS publication can be read here.

If you have any questions about the CMS guidance and proposed changes, our attorneys can help. Please contact Danielle Hildebrand at at 678-325-3872


What Physicians Need to Know About the Stark In-Office Ancillary Services Exception

Stark LawThe Federal Stark Law generally prohibits physicians from referring Medicare/Medicaid payable Designated Health Services (DHS) to any organization in which they have a financial interest, including their own medical practice. Because the Stark prohibition applies when physicians refer their patients within their own practice to obtain DHS, such an arrangement must meet the requirements of an exception in order to comply with the law.

If you are a physician practice that intends to offer to your patients related services which are also DHS, for example, imaging or laboratory services, you might be able to rely upon the In-Office Ancillary Services (IOAS) exception. This exception is designed to protect the provision of Designated Health Services that are truly ancillary to the medical services being provided by your physician practice.

In order to take advantage of this exception, your practice must meet three specific requirements related to

  1. supervision
  2. location
  3. billing

Additionally, multi-physician practices must be considered a “group practice” as provided in the Stark Law.

Physicians providing MRIs, CT and PET scans through their medical practices must also provide a disclosure and notice to patients. Such notice must be in writing and provided at the time of the referral. The notice must disclose to the patient that he or she may obtain those services from other suppliers and provide a list of those suppliers in close proximity to the physician’s office.

Although this exception enables physicians to offer a number of ancillary services and still maintain compliance with the Stark Law, this exception is likely to be restricted in the future. The Department of Health and Humans Services’ (HHS) FY ‘16 proposed budget indicates that HHS intends to limit which practices may offer therapy services, advanced imaging, radiation therapy and anatomic pathology services. Only “clinically integrated” practices that demonstrate cost containment would be able to use the IOAS exception when offering such services.

Additional information on the HHS FY ‘16 Budget Proposal can be found at

If you have any questions about the IOAS exception or need legal advice with respect to offering ancillary services through your practice please contact DJ Jeyaram at or Danielle Hildebrand at