Your Government at Work


HHS and CMS Permit Health Care Flexibility in Response to Puerto Rico Earthquakes

The Secretary of the Department of Health and Human Services (“HHS”) has declared a public health emergency in Puerto Rico in response to the potential public health and safety consequences of recent earthquakes and aftershocks.  With this declaration in effect, the Centers for Medicare & Medicaid Services (“CMS”) has temporarily waived or modified various Medicare, Medicaid, and Children’s Health Insurance Program requirements for Puerto Rico.

This flexibility is meant to ensure that the health care needs of individuals enrolled in these programs continue to be met and that health care providers and suppliers are properly reimbursed and potentially exempted from sanctions for certain good faith instances of noncompliance.  CMS is waiving or modifying certain rules regarding the Health Insurance Portability and Accountability Act, conditions of participation, certification and licensing requirements, and physician referrals.

This declaration and the flexibility arising from it are retroactively effective to December 28, 2019.  More information can be found here and here.

OIG Releases First Advisory Opinion of 2020

The Department of Health and Human Services Office of Inspector General (“OIG”) released its first Advisory Opinion of 2020.  Advisory Opinion 20-01 involves a nonprofit health care system that operates a state-of-the-art training facility where a variety of health care professionals can acquire new skills, refine existing skills, and train in conditions that simulate complex rescue scenarios.  The health care system offers a training facility discount on certain eligible training sessions at this facility.

A local fire department operates an emergency medical service and has used the training facility to train its emergency personnel.  The health care system determined that these training sessions qualified for the training facility discount, and thereby entered into a written arrangement with the fire department for it to receive a discount on a certain number of training sessions per year.  The health care system is now seeking an advisory opinion regarding its discount arrangement with the fire department.

The OIG considered various elements of the arrangement, including the fire department’s use of objectively-based hospital-destination protocols, the type of medical transportation services provided by the fire department, the written arrangement’s express disclaiming of any referral requirements, and the arrangement’s potential benefit to the community.  Based on these considerations, the OIG determined that this arrangement presented a low risk of fraud and abuse.  The OIG ultimately concluded that while this arrangement could potentially generate prohibited remuneration via the anti-kickback statute if the requisite intent to induce or reward referrals were present, it would not impose administrative sanctions under that statute.

CMS Limits the Grounds for Rescinding and Revoking Advisory Opinions

The Centers for Medicare & Medicaid Services (“CMS”) recently made changes to its ability under 42 C.F.R. § 411.382 (“Section 411.382”) to rescind or revoke one of its previously issued advisory opinions.  Prior to this change, Section 411.382 allowed for CMS to rescind or revoke one of its advisory opinions if CMS determined that it was in the public interest to do so.  Now, effective January 1, 2020, Section 411.382 limits CMS’s ability to rescind or revoke one of its advisory opinions to two scenarios: (1) when there is a material change in the law that affects the conclusions reached in an advisory opinion; or (2) when a party that has received a negative advisory opinion seeks a reconsideration of that opinion based on new facts or law.  Section 411.382 now also requires CMS to give advance notice to both the advisory opinion’s requestor and the public regarding its decision to rescind or revoke an advisory opinion.

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