• Raymond "Sonny" O'Kelley

From Stark & Anti-Kickback Statute Enforcement to COVID-19 Blanket Waivers and Back Again?

Updated: Sep 22, 2020

We all know what Stark and the AKS are and how serious HHS and the OIG is/was enforcing them up until COVID-19. In April the Department of Health and Human Services’ Office of the Inspector General said it "...will seek to ensure health care providers retain regulatory flexibility during the COVID-19 crisis...", announcing that it will “exercise enforcement discretion not to impose administrative sanctions under the Federal anti-kickback statute...” for many payments covered by the Blanket Waivers of the Stark self-referral law that CMS published previously. OIG’s statement applies to 11 of the waivers issued by CMS, including compensation for services personally performed by a physician, incidental benefits or loans provided to a physician. I've listed all 18 of them

below for your reading enjoyment.


Question for your Comments: What are the methods and tools that healthcare legal and compliance will deploy to handle this after the blanket waiving ends?


Here's a complete list of the Blanket Waivers:


1. Remuneration from an entity to a physician (or an immediate family member of a physician) that is above or below the fair market value for services personally performed by the physician (or the immediate family member of the physician) to the entity.


2. Rental charges paid by an entity to a physician (or an immediate family member of a physician) that are below fair market value for the entity’s lease of office space from the physician (or the immediate family member of the physician).


3. Rental charges paid by an entity to a physician (or an immed

iate family member of a physician) that are below fair market value for the entity’s lease of Page 4 of 7 equipment from the physician (or the immediate family member of the physician).


4. Remuneration from an entity to a physician (or an immediate family member of a physician) that is below fair market value for items or services purchased by the entity from the physician (or the immediate family member of the physician).


5. Rental charges paid by a physician (or an immediate family member of a physician) to an entity that are below fair market value for the physician’s (or immediate family member’s) lease of office space from the entity.


6. Rental charges paid by a physician (or an immediate family member of a physician) to an entity that are below fair market value for the physician’s (or immediate family member’s) lease of equipment from the entity.


7. Remuneration from a physician (or an immediate family member of a physician) to an entity that is below fair market value for the use of the entity’s premises or for items or services purchased by the physician (or the immediate family member of the physician) from the entity.


8. Remuneration from a hospital to a physician in the form of medical staff incidental benefits that exceeds the limit set forth in 42 CFR 411.357(m)(5).


9. Remuneration from an entity to a physician (or the immediate family member of a physician) in the form of nonmonetary compensation that exceeds the limit set forth in 42 CFR 411.357(k)(1).


10. Remuneration from an entity to a physician (or the immediate family member of a physician) resulting from a loan to the physician (or the immediate fa


mily member of the physician):

(1) with an interest rate below fair market value; or

(2) on terms that are unavailable from a lender that is not a recipient of the physician’s referrals or business generated by the physician.


11. Remuneration from a physician (or the immediate family member of a physician) to an entity resulting from a loan to the entity:

(1) with an interest rate below fair market value; or

(2) on terms that are unavailable from a lender that is not in a position to generate business for the physician (or the immediate family member of the physician).


12. The referral by a physician owner of a hospital that temporarily expands its facility capacity above the number of operating rooms, procedure rooms, and beds for which the hospital was licensed on March 23, 2010 (or, in the case of a hospital that did not have a provider agreement in effect as of March 23, 2010, but did have a provider agreement in effect on December 31, 2010, the effective date of such provider agreement) without prior application and approval of the Page 5 of 7 expansion of facility capacity as required under section 1877(i)(1)(B) and (i)(3) of the Act and 42 CFR 411.362(b)(2) and (c).


13. Referrals by a physician owner of a hospital that converted from a physicianowned ambulatory surgical center to a hospital on or after March 1, 2020, provided that:

(i) the hospital does not satisfy one or more of the requirements of section 1877(i)(1)(A) through (E) of the Act;

(ii) the hospital enrolled in Medicare as a hospital during the period of the public health emergency described in section II.A of this blanket waiver document;

(iii) the hospital meets the Medicare conditions of participation and other requirements not waived by CMS during the period of the public health emergency described in section II.A of this blanket waiver document; and

(iv) the hospital’s Medicare enrollment is not inconsistent with the Emergency Preparedness or Pandemic Plan of the State in which it is located.


14. The referral by a physician of a Medicare beneficiary for the provision of designated health services to a home health agency:

(1) that does not qualify as a rural provider under 42 CFR 411.356(c)(1); and

(2) in which the physician (or an immediate family member of the physician) has an ownership or investment interest.


15. The referral by a physician in a group practice for medically necessary designated health services furnished by the group practice in a location that does not qualify as a “same building” or “centralized building” for purposes of 42 CFR 411.355(b)(2).


16. The referral by a physician in a group practice for medically necessary designated health services furnished by the group practice to a patient in his or her private home, an assisted living facility, or independent living facility where the referring physician’s principal medical practice does not consist of treating patients in their private homes.


17. The referral by a physician to an entity with which the physician’s immediate family member has a financial relationship if the patient who is referred resides in a rural area.


18. Referrals by a physician to an entity with whom the physician (or an immediate family member of the physician) has a compensation arrangement that does not satisfy the writing or signature requirement(s) of an applicable exception but satisfies each other requirement of the applicable exception, unless such requirement is waived under one or more of the blanket waivers set forth above


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About the Author:

As a former United States Marine, “Gunny ROK" O'Kelley retired in 1992 after serving during the Gulf War where he was highly decorated with numerous honors and awards for his performance on active duty. In his earlier years he was a highly recruited Division I football player, spending his time at middle linebacker on the defensive side of the ball. After medically retiring from active duty, Mr. O’Kelley held executive leadership positions at TractManager International, MediTract, Recall (now Iron Mountain) and IKON Office Solutions (now Ricoh).