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HHS Announces Proposed Rules to Reform Stark Law and AKS Regulations

George Indest HeadshotBy 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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New Update to the Medicare Program Integrity Manual Issued by CMS

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

On June 1, 2018, the Centers for Medicare & Medicaid Services (CMS) issued further guidance for reporting and reviewing final adverse legal actions (ALAs) in provider enrollment applications. Section 15.5.3 of the Medicare Program Integrity Manual (MPIM) was updated through Transmittal 797 to provide more guidance on the types of final adverse actions that must be disclosed. It also provides additional instruction to Medicare Administrative Contractors (MACs) on how to process disclosed final adverse actions.

New Language Basics.

The update in Section 15.5.3 of the MPIM clarifies the scope of disclosure, the time frames for disclosure and the evidence needed to support a disclosure.

Per the 2018 update, the list of reportable adverse actions includes: felony and misdemeanor convictions within the last 10 years; current or past suspensions/revocations of a medical license or an accreditation; current or past suspensions or exclusions imposed by the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG); current or past debarments for participation in any Federal Executive Branch procurement or non-procurement program; Medicaid exclusions, revocations, or terminations; and current or past federal sanctions of any type.

New Guidance for MACs.

The second part of the update to the Manual provides additional guidance concerning how MACs will review applications and process the disclosure of final adverse actions. The update also covers how MACs should handle both reported and unreported adverse actions. MACs are now required to use either the Provider Enrollment, Chain and Ownership System (PECOS) or the System for Award Management (SAM) to research whether individuals with ownership interest of the applicant entity are excluded.

To view all the language in Transmittal 797, which outlines the updated Section 15.5.3, click here.

For more information, visit CMS’ website.

Click here to view another recent update issued by CMS.

Contact Health Law Attorneys Experienced in Representing Health Care Professionals and Providers.

At the Health Law Firm we provide legal services for all health care providers and professionals. This includes physicians, nurses, dentists, psychologists, psychiatrists, mental health counselors, home health agencies, skilled nursing facilities (SNF’s) durable medical equipment (DME) suppliers, medical students and interns, hospitals, ambulatory surgical centers, pain management clinics, nursing homes, and any other healthcare provider. We represent facilities, individuals, groups and institutions in contracts, sales, mergers and acquisitions.

The lawyers of The Health Law Firm are experienced in both formal and informal administrative
hearings at both the state and the federal level. We represent health providers in Medicare and Medicaid audits and disputes on a routine basis.

To contact The Health Law Firm, please call (407) 331-6620 and visit our website at www.ThehealthLawFirm.com.

Sources:

King & Spalding. “CMS Updates Rules for Reporting Adverse Legal Action.” JD Supra. (August 25, 2018). Web.

Dhillion, Megan. “Update to the Medicare Program Integrity Manual: New Requirements Related to Disclosing and Processing Final Adverse Actions.” AHLA. (August 24, 2018). 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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“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 © 2018 The Health Law Firm. All rights reserved.

 

Home Health Provider Sues Medicare Contractor and HHS Over Unfair Audit and Denied Medicare Reimbursement Payments

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

On March 2, 2017, an Illinois home health care provider launched a class action law suit against Medicare reimbursement auditor AdvanceMed and the U.S. Department of Health and Human Services (HHS) Secretary Tom Price. MedPro Health Providers LLC (MedPro) filed the complaint in an effort to collect $300,000 it says it is owed in Medicare payments. The complaint was filed in the U.S. District Court for the Northern District of Illinois. The plaintiff, MedPro, which is a home health services provider, seeks status in the law suit as a class representative for all similarly situated health care providers.

The Complaint.

AdvanceMed is a Zone Program Integrity Contractor (ZPIC), which investigates suspected fraud, waste and abuse, according to the Centers for Medicare and Medicaid Services (CMS). Under the Medicare Act, CMS is allowed to enter into contracts with outside organizations to perform certain services, such as those of the ZPIC.

According to allegations made in the complaint, AdvanceMed contended that it found “reliable information” that MedPro had been overpaid for services and stopped reimbursements to the company. When MedPro provided a rebuttal statement to the findings, AdvanceMed allegedly ignored it.

According to the complaint, AdvanceMed’s evaluation of MedPro was not fair. MedPro did not have the opportunity to show its own evidence that its operations were in order. MedPro expended significant resources and financial capital to prepare and transmit the response to AdvanceMed. When AdvanceMed finally responded to its rebuttal, its language was “basically boilerplate” and did not address MedPro’s argument. MedPro said that new HHS Secretary Tom Price should take responsibility for AdvanceMed’s failure to reply as a ZPIC auditor.

So far, MedPro’s fraud allegation is only against AdvanceMed, not Price and HHS. However, in its complaint, it states, “The Secretary, through its ZPICs, has a plainly defined and nondiscretionary duty to properly and completely respond to MedPro’s Rebuttal Statement. MedPro has been irreparably injured because of the Secretary’s failure to carry out that duty.”

To read the complaint in full, click here.

For more information on AdvanceMed and ZPIC Audits, click here and here to read two of my prior blogs.

For a blog I wrote about a similar suit filed against Medicare contractors by the American Hospital Association several years ago, click here.

The Health Law Firm Previously Filed Similar Suit in Michigan.

Prior to MedPro’s class action suit, on September 1, 2016, New Vision Home Health Care, Inc., filed a similar suit in which The Health Law Firm now represents it. It is New Vision Home Health Care, Inc., et al. v. Anthem, Inc. (f/k/a WellPoint, Inc.), TrustSolutions, LLC, and National Government Services, Inc., U.S. District Court for the Eastern District of Michigan, case number 2:16-cv-13173. The New Vision suit did not seek class action status, but raised some of the same legal issues against CMS Medicare contractors. To see a copy of the Second Amended Complaint filed in federal court, click here.

Don’t Wait Until It’s Too Late; Consult with a Health Law Attorney Experienced in Medicare and Medicaid Issues Now.

The attorneys of The Health Law Firm represent healthcare providers in Medicare audits, ZPIC audits and RAC audits throughout Florida and across the U.S. They also represent health care providers in disputes with Medicare, insurance companies and complex litigation. Additionally, they 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.

For more information please visit our website at www.TheHealthLawFirm.com or call (407) 331-6620 or (850) 439-1001.

Sources:

Miesel, Hanna. “Health Provider Sues Medicare Middleman For Reimbursements.” Law360. (March 2, 2017). Web.

“Health Provider Sues Medicare Middleman For Reimbursements.” LexisNexis. (March 2, 2017). 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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“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 © 2017 The Health Law Firm. All rights reserved.