What activities does the Stark Law regulate?

What activities does the Stark Law regulate?

The Physician Self-Referral Law, commonly referred to as the Stark law, prohibits physicians from referring patients to receive “designated health services” payable by Medicare or Medicaid from entities with which the physician or an immediate family member has a financial relationship, unless an exception applies.

What is laboratory compliance?

Laboratory compliance or lab compliance refers to procedures, policy and general approach required in a laboratory to guarantee the analytical results generated are evocative, convincing and appropriate for the decisions which will be made from the data.

What does Stark Law apply to?

The Stark statute applies only to physicians who refer Medicare and Medicaid patients for specific services (“designated health services,” or DHS) to entities with which they (or an immediate family member) have a “financial relationship.” The lists of designated health services and financial relationships addressed by …

How do you comply with Stark Law?

How to Ensure Compliance with Stark Law and Anti-Kickback Policies and Procedures

1. Implementing written policies, procedures and standards of conduct.
2. Designating a compliance officer and compliance committee.
3. Conducting effective training and education.
4. Developing effective lines of communication.

Who regulates Stark Law?

It also goes on to mention that violation of Stark law or anti-kickback statute may also indicate violations of the false claims act. The department of justice, CMS, and the department of health and human services oversees the enforcement of the Stark law.

What is an example of a Stark Law violation?

Entering into contracts with 19 specialist physicians that required the physicians to refer their outpatient procedures to Tuomey in exchange for bribes. Ignoring and suppressing warnings from attorneys that the physician contracts were “risky” and raised “red flags” Filing more than 21,000 false claims with Medicare.

What does a lab compliance officer do?

The laboratory compliance specialist is responsible for maintaining compliance policies, executing compliance training and education, and performing audits; investigating incidents and providing reports on investigations.

What can providers review that will help them understand the compliance requirements of a clinical lab?

What can providers review that will help them understand the compliance requirements of a clinical lab? The OIG Clinical Lab Guidance provides pertinent information on effective compliance and risk areas for laboratories.

What are the exceptions to Stark Law?

For example, the following exceptions to the Stark Law require a written, signed agreement: office space and equipment rental, personal service arrangements, physician recruitment arrangements, group practice arrangements, and fair market value compensation arrangements.

What is the Stark Law in healthcare?

This statute prevents fraudulent and unnecessary testing, referrals, and medical services. Additionally, it prevents physicians from seeking further personal financial or equity gains regarding patient care which is a clear conflict of interest. These limitations impact clinical decision-making and healthcare delivery.

What are the exceptions under Stark Law?

What does Stark Law prohibit?

The Physician Self-Referral Law, also known as the “Stark Law,” generally prohibits a physician from making referrals to an entity for certain healthcare services, if the physician has a financial relationship with the entity.

What do you need to know about the Stark laws?

What are the “Stark Laws”. The Stark laws (passed in 1992 and expanded on in 1995) prohibit referral of a patient for “designated health services” to an entity in which the referring physician – or a family member– has a financial interest. A financial interest includes compensation, ownership and investment interests.

How does Stark Law apply to physician compensation?

If the methodology used to determine the physician’s compensation or the payment from the physician does not fall squarely within the defined circumstances, the compensation does not take into account the volume or value of the physician’s referrals or other business generated by the physician, for purposes of the Stark Law.

When did the HHS finalize the Stark rule?

On November 20, 2020, the US Department of Health and Human Services (HHS) released final rules amending the regulations to the physician self-referral law (Stark Law) ( Stark Rule) and the Anti-Kickback Statute (AKS) and Beneficiary Inducement Civil Monetary Penalty Law (CMPL) (collectively, AKS Rule ).

When did CMS propose changes to the Stark Law?

Then, on October 9, 2019, CMS and OIG simultaneously proposed rules significantly modifying the Stark Law and the AKS. See ( Stark Proposed Rule) and ( AKS Proposed Rule ).