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Changes to Anti-Kickback Safe Harbors

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On October 9, 2019, the Office of Inspector General (OIG) published proposed revisions to the federal Anti-Kickback Statute (AKS). If they are passed, the changes would affect regulatory safe harbors. There are several key points targeted to change, which include how payments are made, warranties, and transportation.

The AKS is a well-known, wide-ranging fraud and abuse statute, and applies to pharmaceutical, health care, and medical device industries. It prohibits these business sectors from engaging in transactions that are set up to reward or reward others for referrals that are reimbursed by federal health care programs, such as Medicare. It is a criminal statute and applies to referred services and items. The AKS was designed to combat corruption and to shield program beneficiaries from low quality, higher costs, and overutilization. One of its main goals is to prevent people from using money and favor to influence referral decisions.

What is a Safe Harbor?

The original AKS regulations make use of safe harbors, which are certain business practices and payments that are not considered offenses under this statute, even though they may implicate it. Some of these exceptions include payments made to lease equipment or space, investment interests, and certain warranties and discounts. Some of the proposed revisions to these safe harbors are described below.

Professional Services and Management

Health care providers enter contracts with other parties, and in these situations, one party will agree to provide the other with professional or management services. If one can refer services that are reimbursable by a federal health care program, the AKS should be considered. The OIG’s plan would change the requirement that applies to compensation, require a specified schedule of services, and change how outcomes-based payments are handled. Outcomes-based payments will need to show that they improve the quality of patient care or reduce payor costs while improving or maintaining the quality of patient care.

Warranties and Local Transportation

The proposed OIG rules would also change the warranty safe harbor by expanding it to include certain bundled warranties and would disallow suppliers and manufacturers to mandate a buyer’s minimum purchase or exclusive use of their products. In addition, beneficiaries would be excluded from certain reporting requirements.

Local transportation safe harbors may also be affected by these rules, which apply to mileage limits. The limits would be eliminated for patients being discharged from inpatient facilities to their homes. Mileage limits would also be increased from 50 to 75 miles for patients traveling from a facility to a rural residence.

Philadelphia Physician Lawyers at Sidney L. Gold & Associates, P.C. Help Physicians with Anti-Kickback Statute Concerns

It can be difficult to understand AKS laws, so it is smart to have the knowledgeable Philadelphia physician lawyers at Sidney L. Gold & Associates, P.C. on your side. Call us at 215-569-1999 or complete our online form for a free case evaluation today. Located in Philadelphia, we serve clients throughout Wilkes-Barre, Scranton, northeast Philadelphia, Bucks County, Chester County, Delaware County, and Montgomery County.

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