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HHS Announces Proposed Rules to Reform Stark Law and AKS Regulations

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
On October 9, 2019, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued two proposed rules to reform the federal Stark Law (dealing with prohibited self-referrals) and Anti-Kickback Statute (AKS) (addressing giving or receiving any thing of value in exchange for a patient referral) regulations.

The long-awaited proposed rules aim to “modernize and clarify” federal laws relevant to value-based and patient coordinated care programs. The proposals would ease the compliance burden for healthcare providers across the industry while maintaining strong safeguards to protect patients and programs from fraud and abuse.

The Proposed Stark Rule.

The proposed rule that would further implement and clarify the Stark Law, “Modernizing and Clarifying the Physician Self-Referral” would, if finalized, create new exceptions to the existing Stark Law for value-based arrangements, according to CMS. These exceptions would apply broadly to care provided to all patients, not just Medicare beneficiaries, CMS said. The proposed rule also includes additional clarifications and guidance on key statutory terms and other technical compliance requirements.

For more info, click here to view the Stark proposed rule’s fact sheet issued by CMS.

The Proposed AKS Rule.

The proposed rule to further implement and clarify the AKS, “Revisions to the Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements” would make several changes to the AKS and beneficiary inducement provisions of the Civil Monetary Penalties Law (CMP). These changes would include the addition of several new AKS safe harbors for certain remuneration exchanged between or among eligible participants.

The new AKS safe harbors include care coordination arrangements aimed at improving quality and outcomes; value-based arrangements with substantial downside financial risk; and value-based arrangements with full financial risk, according to OIG.

Click here to view the fact sheet issued by CMS to learn more about the proposed rule.

To view the press release issued by the HHS in full, click here.

Contact Health Law Attorneys Experienced in Handling Stark Law and Anti-Kickback Statute Compliance.

If you are involved in referring or providing DHS, your arrangements must be reviewed for compliance with Stark and other anti-fraud laws. Violations of these laws can carry severe financial and criminal penalties. One of the best ways to avoid these sanctions is to have your current or potential arrangement reviewed by an attorney who is experienced in these matters.

The Health Law Firm routinely advises healthcare providers on Stark compliance issues for practitioners and providers of all types of DHS. We can advise you on the legality of a particular arrangement and can assist with remedying any perceived compliance issues. Our attorneys also represent providers in cases of medical billing fraud, overbilling, Medicare audits, ZPIC audits and RAC audits, False Claims Act cases, and whistleblower/qui tam cases throughout Florida and across the United States.

They also represent physicians, medical groups, nursing homes, home health agencies, pharmacies, hospitals and other healthcare providers and institutions in Medicare and Medicaid investigations, audits, recovery actions and termination from the Medicare or Medicaid Program.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Sources:

Kearbey, Amy. “CMS Publishes Proposed Amendments To Stark Law Advisory Opinion Regulations.” The National Law Review. (October 9, 2019). Web.

HHS Press Office. “HHS Proposes Stark Law and Anti-Kickback Statute Reforms to Support Value-Based and Coordinated Care.” HHS.gov, U.S. Department of Health & Human Services. (October 9, 2019). Web.

“CMS, OIG Release Long-Awaited Stark, AKS Proposed Rules.”AHLA. (October 9, 2019). Web.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

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Health Care Professionals Need to be Compliant with Anti-Fraud Laws

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The federal government has several tools available to help combat Medicare fraud. Among those are the Stark Act, Anti-Kickback laws and Civil Monetary Penalty Laws. Each of these typically focuses on a particular type of behavior that is prone to abuse by health care providers.

The Stark laws exist to combat the problems that can arise from physician self-referrals. Self-referrals are cases in which a physician orders a test or service and refers the patient to a provider in which the referring physician has a financial interest. This second provider will then bill Medicare for the service, essentially allowing the referring physician to cash in twice.

The concern is that if physicians are permitted to benefit from referring to an entity, they will be prone to order tests and services that are not medically necessary. I previously wrote an article on the legal ramifications of unnecessary tests, which was published in Medical Economics. Click here to read that article.

Obligations for Compliance.

Stark compliance is a two-way street. Not only is the physician prohibited from referring to an entity in which he has a non-exempt financial interest, the provider receiving the referral is prohibited from accepting it.

Medicare conditions payment of a claim upon the certification by the claimant that it is in compliance with the Stark law. What this means is that there is an obligation on the recipient of a referral to make sure that it is proper.

In the complicated world of healthcare business entities, it is incumbent upon the management of a supplier of Designated Health Services (DHS) to know who all of its owners, investors, and stakeholders are so that it can remain in compliance and avoid any charges of impropriety.

Exceptions to Stark Law.

Like many other regulatory frameworks, the Stark law have exceptions. The law provides a number of exceptions to the rules which allow otherwise impermissible referral arrangements to pass muster.

Because the exceptions are numerous and often subject to change, it is highly recommended that any new business arrangement, or substantial change to an existing one, is reviewed by a health law attorney experienced in the area of Stark law.

Contact Health Law Attorneys Experienced in Handling Stark Compliance.

If you are involved in referring or providing DHS it is crucial that your arrangements are reviewed for compliance with Stark and other anti-fraud laws.

Violations of these laws can carry severe financial and criminal penalties. One of the best ways to avoid these sanctions is to have your current or potential arrangement reviewed by an attorney who is experienced in these matters.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

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“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999. Copyright © 2018 The Health Law Firm. All rights reserved.