HHS Issues Two Proposed Rules to Reform Stark Law and AKS Regulations

Wednesday, November 6, 2019
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.


KeyWords: Healthcare fraud representation, healthcare fraud lawyer, healthcare fraud defense attorney, Stark Law defense, Stark Law representation, Anti-Kickback Statute (AKS) representation, AKS defense, AKS lawyer, AKS representation, Centers for Medicare & Medicaid Services (CMS), CMS representation, CMS defense attorney, CMS lawyer, representation for CMS investigation, Whistle blower plaintiff-relator attorney, Qui tam suit plaintiff-relator attorney, False Claims Act suit plaintiff-relator attorney, Medicare audit defense attorney, Medicare audit defense legal representation, Medicare audit defense lawyer, Medicaid audit defense attorney, Medicaid audit defense legal representation, Medicaid audit defense lawyer, Medicaid  Fraud Control Unit (MFCU) defense attorney, Medicaid  Fraud Control Unit (MFCU) defense legal representation, Medicaid Fraud Control Unit (MFCU) defense lawyer, Medicare overpayment demand defense attorney, Medicare overpayment demand defense legal representation, Medicare overpayment demand defense lawyer, Office of Inspector General (OIG) investigation defense attorney, Office of Inspector General (OIG) investigation defense legal representation, Office of Inspector General (OIG) investigation defense lawyer, Civil Monetary Penalty defense attorney, Civil Monetary Penalty defense legal representation, Civil Monetary Penalty defense lawyer, Whistle blower suit defense attorney, Whistle blower suit defense legal representation, Whistle blower suit defense lawyer, Qui tam suit defense attorney, Qui Tam suit defense legal representation, Qui tam suit defense lawyer, False Claims Act suit defense attorney, False Claims Act suit defense legal representation, False Claims Act suit defense lawyer, representation for allegations of overbilling, representation for FCA investigations, Office of Inspector General (OIG) interview defense attorney, Office of Inspector General (OIG) interview defense legal representation, Office of Inspector General (OIG) interview defense lawyer, reviews of The Health Law Firm, The Health Law Firm attorney reviews

"The Health Law Firm" is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2019 The Health Law Firm. All rights reserved.
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law 11/6/2019

Like this blog? Add your public comments:

Items in bold indicate required information.