CMS proposed updates to the Stark Law: Comment now

November 8th, 2019 / By Barbara Aubry, RN

While reading a recent CMS release regarding proposed updates to the Stark Law, I was reminded that it was first released in 1998. With value-based reimbursement, relationships between providers has changed. The latest from CMS:

“This proposed rule would address any undue regulatory impact and burden of the physician self-referral law. This proposed rule is being issued in conjunction with the Centers for Medicare & Medicaid Services’ (CMS) Patients over Paperwork initiative and the Department of Health and Human Services’ (the Department or HHS) Regulatory Sprint to Coordinated Care. This proposed rule proposes exceptions to the physician self-referral law for certain value-based compensation arrangements between or among physicians, providers, and suppliers. It would also create a new exception for certain arrangements under which a physician receives limited remuneration for items or services provided by the physician; create a new exception for donations of cybersecurity technology and related services; and amend the existing exception for electronic health records (EHR) items and services. This proposed rule also provides critically necessary guidance for physicians and health care providers and suppliers whose financial relationships are governed by the physician self-referral statute and regulations.”

If Stark currently impacts segments of your value-based practice, there is still time to comment, but your input will need to be received by CMS no later than 5:00 PM on December 31, 2019. If you are interested in commenting, please refer to the following CMS guidelines:

“Refer to file code CMS-1720-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. You may submit comments in one of four ways (please choose only one of the ways listed):

    1. Electronically. You may submit electronic comments on this regulation to http://www.regulations.gov. Follow the “Submit a comment” instructions.
    2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1720-P, P.O. Box 8013, Baltimore, MD 21244-1850. Please allow sufficient time for mailed comments to be received before the close of the comment period.
    3. By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1720-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    4. By hand or courier. Alternatively, you may deliver (by hand or courier) your written comments ONLY to the following addresses prior to the close of the comment period:
    5. For delivery in Washington, DC—Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue SW, Washington, DC 20201.

(Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without Federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)”

For delivery in Baltimore, MD—Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.

My Take

I am glad to see the proposal, which is especially important to those providers involved in testing value-based programs. The proposed change also allows for donations to certain cybersecurity initiatives. There is also a section that addresses issues with EHRs. Please look at the comments (402 at the date this blog was written) and add your input if you are impacted. It is time Stark Law is brought into the 21st century.

Barbara Aubry is a regulatory analyst for 3M Health Information Systems.