There are many laws in place to prevent physician fraud and abuse, such as the Stark Law and Anti-Kickback laws. These are enforced by the Office of Inspector General (OIG) of the Department of Health & Human Services, the Centers for Medicare & Medicaid Services (CMS), and other government agencies. Understanding and following these laws is critical for physicians because a violation can lead to civil fines, criminal penalties, the loss of a medical license, and exclusion from federal health care programs.
In early December of last year, the OIG and the CMS issued two final rules that applied to the Stark Law and the Anti-Kickback Statute (AKS). These changes are meant to remove some regulatory barriers with the goal of improved patient care and a more value-based health system. These went into effect on January 19, 2021.
What are the Changes to the Stark Law?
The new rules establish value-based exceptions to allow compensations for doctors and entities that pay them based on the quality of care instead of the volume of services that are provided. There is also a cybersecurity exception that allows entities to donate cybersecurity services, hardware and software, when needed in certain circumstances. Another rule applies to limited renumeration; there is now an exception that permits physicians to receive this out of a maximum of $5,000 each year in exchange for items or services that are provided.
There is a total of nine new Stark Law rules. The others focus on similar topics, and one clarifies the value standard, fair market value requirements, volume, and commercial reasonableness of specific business arrangements between physicians and companies. There is also numerous other updates.
What are the Anti-Kickback Changes?
The first exception focuses on value-based arrangements. There are three new safe harbors for renumeration; the first is for care coordination arrangements. The second safe harbor is for value-based arrangements with at least five percent financial risk or with full financial risk with certain limitations.
The CMS finalized a new safe harbor for sponsored models to create greater predictability for model participants and greater uniformity across models. With this safe harbor, the need for separate fraud and abuse waivers for new innovative models should be reduced. The CMS now has new protections for their sponsored models, which should reduce the need to separate fraud and abuse waivers.
How can I Stay Compliant with the AKS?
These laws are complex, but there are ways that physicians can stay compliant with the Stark Law and AKS. To start, physicians who deal with hospitals should be wary of accepting gifts or other forms of compensation. This is tracked by hospitals for compliance purposes. Also, hospital payment rates should always be negotiated in advance and paid as noted in a contract.
Threatening to stop referring patients to a hospital in the middle of negotiations is also against AKS rules. Furthermore, if a doctor threatens that they will discontinue sending referrals to any other organization it can appear as retaliation or that the doctor was sending over referrals in order to get reimbursed.
It is best to never accept payments or other kinds of compensation for referrals. All payments should be of a fair market value, even if hospital administrators are not concerned. Making comments about being able to increase the hospital’s business during negotiations is also discouraged since it could be seen as trying to get the hospital to pay for referrals.
How can I Stay Compliant with Stark Law?
The Stark Law requires that physicians follow prudent business arrangements without referrals and also prohibits certain compensation arrangements. It prohibits doctors from referring designated health services (DHS) to a Medicare or Medicaid patient when the doctor has some type of financial relationship with the referred entity. Billing for certain services can be illegal unless there is an exception.
Physicians can also take care to keep employment relationships, office spaces, equipment rentals, and personal services separate from their practices. If their compensation includes recruiting other physicians, incentive plans, and other group practice arrangements, they could be vulnerable to violations.
The CMS and the OIG established fraud waivers with respect to physician incentives based on money, goods, or services provided to referring physicians who participate in value-based incentive programs. These waivers are detailed, and it is suggested to become familiar with them.
Should I Accept Gifts?
The OIG states that any actions that involve pharmaceuticals or other kinds of gifts and benefits should be studied carefully by the provider. If a gift or service is given to someone who has the power to generate more business for the person offering the gift, this may not be a good idea. The receiving party should also determine if the gift or benefit is in any way related to a referral of federal health care business or the generated volume of the business.
Fair market value also comes into play. A gift or benefit that exceeds fair market value for a legitimate service provided to a payer could also lead to a violation.
Will Better Recordkeeping Help?
This is highly recommended, especially since many physicians do not even realize that they are breaking the AKS or the Stark Law. Recordkeeping can include establishing time logs for every activity that does and does not relate to patient or clinical care. This way, there is documentation that can substantiate payments.
Time logs should always be reviewed before payments are made. Reviews can check to ensure that the work was performed by the doctor and that the original financial agreement is being followed to the letter. During this phase, every payment should be compared to the contract. Some of these agreements have annual maximums, and reviewing payments in isolation can lead to errors. Many offices have automated time logs and payment procedures, which can prevent human errors.
It is also wise to design and implement a compliance program. The OIG provides compliance guidance to all providers who have business with Medicare and Medicaid, as well as other federally-funded health care agencies and programs. This helps practices and providers develop procedures and standards that they can follow. It is also recommended to never offer inappropriate incentives to patients. Examples of this would be offering to waive deductible or coinsurance payments or cost-sharing portions that they owe.
If a physician is being accused of an AKS or Stark Law violation, they should speak to a lawyer. A lawyer will be able to advocate on behalf of their client.
Philadelphia Physician Lawyers at Sidney L. Gold & Associates, P.C. Help Physicians Concerned with Stark Law and Anti-Kickback Violations
Violating the Stark Law or AKS can have serious repercussions. Our Philadelphia physician lawyers at Sidney L. Gold & Associates, P.C. have the knowledge and experience to help you with your case. For a free consultation, complete our online form or call us at 215-569-1999. Located in Philadelphia, we serve clients throughout Wilkes-Barre, Scranton, northeast Philadelphia, Bucks County, Chester County, Delaware County, and Montgomery County.