stark law, anti-kickback statute, arrangements review & … · 2019-05-01 · 3. developing and...

Annual General Compliance, Stark Law & Anti-Kickback Statute Training with additional Arrangements & Physician Relationship Policy

Compliance & Ethics

Class 202b

Audience: Focus Arrangements

Compliance with Arrangements

Revised: 5-01-2019

Training Objectives • Corporate Integrity Agreement (CIA)• Compliance Program Overview• Code of Conduct Overview• Compliance & Ethics Policy Overview• Federal Health Care Program Requirements,

Required Exclusions• Risk Assessment & Internal Review Overview• HIPAA Overview

• Stark & Anti-Kickback Statues

• Recent Settlements/Penalties

• Compliance with Arrangements – Specific policies relating to relationships with Sources of Recipients of Health Care Business, Physician Relationships and other Stark & Anti-Kickback information

• Compliance Hotline – Disclosure Program

Corporate Integrity Agreement (CIA)

Settlement with Federal Government

• Up to $13Million

• 5 Year Compliance Obligation

Corporate Integrity Agreement Facts

• Term of Agreement: November 16, 2017 – November 15, 2022

• Between OIG and Meadows Regional Medical Center, Inc.

• 2nd Year Reporting Period (11/17/2018 – 11/16/2019)


Meadows Requirements under the CIA

Create & Implement the following:

• Board Resolution & Commitment

• Development of special Policy & Procedure

• Code of Conduct, Compliance Program

• Focus Arrangements Procedures

• Disclosure Program

• Contract with an Independent Review Organization (IRO) Annual Review

• Annual Risk Assessment

• Annual Education Plan

Arrangements

Focused Arrangements

Covered Persons

Arrangements Covered Persons

Under a CIA, each defined type of relationship has specified requirements:


• Record Retention

• Responsibilities & Liabilities

• Risk Assessment & Internal Review Process

• And More!

• Contracted Relationships

• Education/Training

• Access to our Policy & Procedure

• Screening for Ineligible Person or Exclusions

Types

Compliance & Ethics Policy Manual

You have access to our Policy Manual via our website

1) Turn your web browser to www.meadowshealth.com2) Select “About Us”3) Select Compliance & Ethics

Compliance & Ethics Policy Manual

1) Select Policies & Procedures2) Identify the policy to view and select the hyperlink

Compliance Program

Meadows Health Compliance & Ethics ProgramPURPOSE

• MMRMC has adopted a Compliance Program (“Compliance Program”) and is committed to establishing and observing high standards and ethical conduct in its business and operational practices conforming to the standards set forth in the Federal Sentencing Guidelines. The Compliance Program shall be a Meadows Health corporate-wide Program, applicable to MRMC and all of its subsidiaries, and structured to encourage collaborative participation at all levels. The Compliance Program shall focus on the detection and prevention of violations of federal, state and local laws. The Compliance Program shall foster an environment in which employees and affiliated professionals comply with all relevant laws and regulations and report any concerns about business practices as set forth under this Program. The Compliance Program has been developed in consideration of Meadows Health vision, mission and values

Compliance Program

Meadows Health Compliance & Ethics ProgramOUR CORE ELEMENTS

The Compliance Program reflects the organization's commitment to identify and reduce risk, to improve internal controls, and to establish system-wide standards. As such, Meadows Health has adopted the following principles of compliance:

1. Developing and distributing a written Code of Conduct, as well as written policies and procedures promoting our commitment to compliance, providing general and specific operational guidance, and identifying specific areas of risk.

2. Designating a CCO and Compliance Oversight Committee charged with the responsibility of operating and monitoring the Compliance Program.

3. Developing and implementing regular, effective education and training programs for all MH employees, officers, the Board of Directors and medical staff members.

4. Maintaining an effective and well-publicized disclosure program to provide guidance and receive complaints about potential Compliance Program violations without fear of retaliation.

Compliance Program

Meadows Health Compliance & Ethics ProgramOUR CORE ELEMENTS

5. Developing disciplinary standards and appropriate employment, contracting and credentialing criteria to respond to allegations of improper or illegal activities, and carrying out the equitable enforcement of these standards on associated individuals who have violated laws, regulations, other federal health care program requirements or the Compliance Program standards.

6. Maintaining effective auditing and monitoring systems and protocols to evaluate compliance with applicable laws, regulations, other federal healthcare program requirements and the Compliance Program standards; to assist in the prevention of Compliance Program violations; and to maintain the efficacy of the Compliance Program.

7. Investigating, responding to and preventing identified compliance problems, including establishing appropriate and coordinated corrective action measures.

8. Developing and implementing an annual risk assessment in effort to self-identify potential areas of compliance violation.

Code of Conduct• Our Code of Conduct Policy provides

guidance regarding our policy and expectations relating to business conduct.

• The next six slides will provide an overview but we recommend that you review the Code of Conduct in its entirety.

• You have access to this policy via the www.meadowshealth.com

Code of Conduct

Purpose of the Code of Conduct• The Code of Conduct summarizes our organizations policies and beliefs for proper business conduct and supports

our Mission and Values.

• Meadows Health Code of Conduct applies to every member of Meadows Health—Board members, administration, Medical Staff members, volunteers, employees, vendors, students and independent contractors. All members of Meadows Health must abide by the Code of Conduct. For employees, abiding by this Code of Conduct is a condition of employment. Employees violating the Code of Conduct will face disciplinary action, which may include termination, depending upon the severity of the violation committed. Independent agents violating the standards established in the Code of Conduct will face termination of their business relationship with Meadows Health. Always remember that the Code of Conduct is intended to serve as a guide in directing the ethical and legal conduct of our organization. Because it is impossible to discuss every situation that an individual may face in the course of business, we encourage you to use your personal judgment and common sense in selecting the best course of action. We also encourage you to bring forward all questions regarding the Code of Conduct and other policies, if you believe that a certain policy or practice is not in the best interest of a patient, employee or the Organization.

Code of Conduct

Physicians and Other Healthcare Providers• Federal and state laws govern the relationship between Meadows Health and physicians and other healthcare

providers who may refer patients to Meadows Health. It is important that those employees who interact with physicians and other healthcare providers, particularly those employees involved in making payments for services rendered, providing space or services, recruiting to the community and arranging for physicians and other healthcare providers to serve in leadership positions, are aware of and follow these laws, regulations and policies.

• Any arrangement with a physician must be structured to ensure compliance with legal requirements, policy and procedures. Such arrangements must be in writing and a review by the Legal Department and/or Compliance Department is required prior to incurring any obligation resulting in payments being made.

• Meadows Health does not pay for referrals. We accept patient referrals based on the patient’s medical needs and our ability to render services. We do not take into account the volume or value of the referrals that a provider makes when making patient referrals to another healthcare provider. We do not accept payment for referrals Meadows Health makes to other healthcare providers.

Code of Conduct

Employees Receiving Business Courtesies

• Gifts: As a general rule, employees are discouraged from accepting gifts from a current or potential business associate. Gifts of a personal nature, including cash, should never be accepted or solicited from patients or their family members. Perishable or consumable gifts, such as a cookie tray and floral arrangements given to a department or group, are not subject to any specific dollar limit. (Please see Human Resources Policy: Prohibition against Gifts, Gratuities and Tips & Compliance Policy: Business Gifts and Entertainment Policy for more details.)

• Reporting Receipt of Gifts: Employed providers (physicians and other non-physician providers) should report your receipt of gifts through the Business Gifts & Entertainment Disclosure Log. This tracking mechanism is available to all team members and assist the Compliance Department with annual tracking. Gifts should not be cash or cash equivalent such as gift certificates or cards that can be exchanged in whole or in part for cash. The gift may not be solicited and each occurrence must be of a nominal value. Meadows defines nominal as value of less than $35.00. We are also required to ensure that total annual value of all benefits/gifts is less than our policy maximum. Please note that gifts provided to an immediate family members should also be reported. Call 912-538-5898 for additional information on how to report or visit our MRMC Connect Site

Business Gifts & Entertainment Disclosure Log

https://sites.google.com/a/meadowsregional.org/mrmc/departments/compliance-home/business-gifts-entertainment-disclosure-log



Code of Conduct

Meadows Extending Business Courtesies & Tokens of Appreciation to Referral and Potential Referral Sources: Physicians & Other Healthcare ProvidersMeadows staff giving a benefit/gift to one or more potential Referral Sources must submit a completed Physician Non-Monetary Benefit/Gift Disclosure Form detailing information such as date given, purpose of the benefit/gift, benefit/gift’s value, recipient’s name and name of the Meadows Health Senior Executive approving the benefit/gift, in addition to other information, to the CCO. If you are not sure if your benefit/gift, when added to all the other benefits/gifts received by a Referral Source will exceed the annual limit, call the CCO before buying or giving the benefit/gift. Meadows Health may provide Physicians with certain limited incidental benefits such as those specified in the physician’s employment agreement or typically provided to Referral Sources regardless of whether they make referrals to Meadows Health or generate other business with Meadows Health.

In addition, Meadows Health may provide incidental benefits in the form of items/services (not including cash or cash equivalents) to a member of the medical staff when the item/services meet all the following conditions:• The item/service is provided to all members of the medical staff practicing in the same specialty without regard to the volume or

value of referrals.

Code of Conduct

Meadows Extending Business Courtesies & Tokens of Appreciation to Referral and Potential Referral Sources: Physicians & Other Healthcare ProvidersContinued….

• Except with respect to identification of medical staff on a hospital Web site or in hospital advertising, the item/service is provided only during periods when the medical staff members are caring for patients or on other hospital business.

• The item/service is provided by the hospital and used by the medical staff members only on the hospital’s campus.

• The item/service is reasonably related to the provision of, or designed to facilitate directly or indirectly the delivery of, medical services at the hospital.

• The item/service is of low value, i.e. $35.00.

• The item/service is not determined in any manner that takes into account the volume or value of referrals or other business generate between the parties.

• The item/service does not violate the federal Anti-kickback statute, section 1128B of the Social Security Act or any federal or state law or regulation governing billing or claims submission.

Code of Conduct

Laws, Regulations and StandardsFraud and Abuse Prevention and Whistleblower Protection

• The Medicare/Medicaid fraud and abuse provisions make it a crime for a person to offer or pay someone else an incentive for referring Medicare or Medicaid patients. These provisions also make it illegal to file a false claim for Medicare or Medicaid reimbursement. No employee should ever receive, offer or pay funds, incentives or anything of value to another person or medical facility in exchange for a patient referral. Meadows Health is committed to complying with the False Claims Act and to detecting and preventing fraud, waste and abuse. The first step in the prevention of fraud, waste and abuse is to ensure that all documents submitted by Meadows Health to any government entity are truthful and accurate.

Compliance & Ethics Overview

NOTIFICATION OF INVESTIGATIONS, OVERPAYMENTS AND REPORTABLE EVENTS

Meadows has an obligation to identify any overpayment received or any charge from Meadows to a Federal or State Health Care Program.

We follow our policy and make prompt refunds, when applicable

OFFICE OF INSPECTOR GENERAL – EXCLUSION CHECKS

It is the policy of Meadows Regional Medical Center and its affiliates (“MRMC”) not to employ, contract with, grant medical staff privileges to or otherwise do business with any Covered Person (individual or entity) excluded from participation in federally or state sponsored health care programs, such as Medicare and Medicaid. Additionally, pending the resolution of any criminal charges or proposed debarment or exclusion, individuals and entities with whom MRMC currently contracts, employs or credentials who are charged with criminal offenses related to health care, or proposed for debarment or exclusion, should be removed from direct responsibility for or involvement in any federally-funded health care program. If resolution results in conviction, debarment or exclusion of the individual or entity, MRMC will immediately cease contracting, employing or credentialing that Ineligible Person.

RISK ASSESSMENT & INTERNAL REVIEW PROCESS

The Chief Compliance Officer completed the 2019 Risk Assessment in 4Q2018.

The results of the Initial Risk Assessment will be the basis for developing our internal review processes.

Departments with responsibilities tied to focused arrangements, billing & coding, or other identified risks, have developed internal monitoring and auditing programs.

HIPAA

• Meadows Health is committed to protecting the privacy of our patients’ Protected Health Information (PHI); providing for the physical and electronic security of PHI; simplifying billing and other transactions with standardized identifiers, code sets and electronic transactions; and supporting the rights of patients to access their PHI and to have some control over the uses of their PHI. We must never disclose confidential information that violates the privacy and rights of our patients. In compliance with HIPAA, we do not disclose or discuss patient information unless necessary for patient care or required by law.

Administration Policy: Confidentiality of Patient Information (HIPAA Compliance)

HIPAA = Health Insurance Portability & Accountability Act

HIPAA

Our Rules:

Individuals acting on behalf of Meadows Regional Medical Center, Inc. must always use only the minimum amount of information necessary to accomplish the intended purpose of the use, access, or disclosure.

• Discussion of patient related information should be conducted only in locations where confidentiality can be maintained. No employee or volunteer shall discuss specific patient cases with each other in public areas such as hallways, elevators, waiting areas, or cafeterias.

• Health care providers should use discretion when discussing medical information concerning a patient in front of visitors or family members, and should first determine whether the patient wishes to have this information discussed in the presence of such persons. In addition, the patient's permission should be obtained prior to leaving a message containing confidential medical information on a telephone answering machine, or with family and/or household members.

• Employees should not disclose patient related information when asked by unidentified or unknown persons, or in response to telephone inquiries.

• Requests by News Media: Refer to Administrative policy "Media Policy".



HIPAA

Our Rules:

• Unattended patient-specific information or medical records, including patient information on computer screens shall not be left in areas where the public could view.

• No employee shall access test results, diagnostic, or demographic information of patients known to them, including spouse, family members and friends, without the patient's specific written authorization except as required to fulfill Meadows Regional Medical Center, Inc job responsibilities.

• Access to patient information via the hospital's information system will be protected according to hospital policy, with access code and password security maintained. An individual system user is only to access what they need to perform his or her job.

• Employees shall only access patient confidential information when there is a legitimate need to know. No one shall allow unauthorized individuals access to confidential patient information.

• Staff should be sensitive to the fact that fellow employees often obtain their health care at Meadows Regional Medical Center, Inc. It is never appropriate for employees to reveal information, including incidental observations, about fellow employees receiving care at Meadows Regional Medical Center, Inc.

• All employee/volunteers of Meadows Regional Medical Center, Inc shall be informed of the confidentiality policies at the time of employment, and are required to sign a Confidentiality Statement.



Meadows Health - Compliance & Ethics Policy

Anti-Kickback and Stark Law PolicyIt is the policy of Meadows Health to comply with the Anti-Kickback Statute by prohibiting specific categories of referral payments, including kickbacks, bribes, or rebates. Any knowing and willful conduct involving the solicitation, receipt, offer, or payment of any kind of remuneration in return for referring an individual or recommending or arranging the purchase, lease, or ordering of an item or services that may be wholly or partially paid for under a federal health care program is prohibited.

Our organization shall also comply with the Stark Law by prohibiting a physician from making referrals for certain designated health services (DHS) to an entity with which he or she (or a statutorily defined family member) has a financial relationship (ownership, investment, or compensation), unless an exception applies.


ANTI-KICKBACK STATUTE

The federal Anti-Kickback Statute prohibits the knowing and willful solicitation, offer, payment or acceptance of any remuneration (including any kickback, bribe or rebate) directly or indirectly, overtly or covertly, in cash or in kind:

for referring an individual for a service or item covered by a federal health care program, or

for purchasing, leasing, ordering, or arranging for or recommending the purchase, lease, or order of any good, facility, service or item reimbursable under a federal health care program.



Violation of the Anti-Kickback Statute is a felony, punishable by up to five years imprisonment and/or a $25,000 fine. In addition, violation can result in exclusion from federal health care programs, including Medicare and Medicaid, and parallel loss of state licensure, hospital privileges and participation in managed care contracts.

Meadows Health Personnel are strictly prohibited from soliciting or accepting anything of value in exchange for individual referrals or in exchange for purchasing or leasing any item or services which may be reimbursed by Medicare, Medicare, or any Federal or State health care program.



The Anti-Kickback has statutory exceptions for:Bona fide payments to W-2 employees;Discounts;Payments to purchasing agents;Certain transactions that fit within “Safe Harbors”;Specific risk-sharing arrangements; andPrescription drug discounts for certain beneficiaries.


STARK LAW

The Stark Law:Prohibits a physician from making referrals for certain designated health services (DHS) to an

entity with which he or she (or an immediate family member) has a financial relationship (ownership, investment, or compensation), unless an exception applies.Prohibits the entity from presenting or causing to be presented claims (or billing another

individual, entity, or third party payer) for the designated health services furnished under the prohibited referral.Establishes a number of exceptions and grants the secretary of HHS the authority to create

regulatory exceptions for financial relationships that do not pose a risk of program or patient abuse.


STARK LAWThe following items or services are Designated Health Services:Clinical laboratory services;Physical therapy services;Occupational therapy services;Outpatient speech-language pathology services;Radiology and certain other imaging services;Radiation therapy services and supplies;Durable medical equipment and supplies;Parenteral and enteral nutrients, equipment, and supplies; Prosthetics, orthotics, and prosthetic devices and supplies;Home health and hospice services;Outpatient prescription drugs; and Inpatient and outpatient hospital services.


STARK LAW

The Stark Law is not an intent based statute. Therefore, receipt of a referral from a physician where a relationship exists results in a violation of the Stark Law, regardless of intent.

Under the Stark Law, Meadows cannot accept referrals for DHS from a physician with whom Meadows has a financial relationship, unless a relevant exception applies.


STARK LAW

A financial relationship between Meadows and a physician will be deemed to exist if a physician (or a family member of the physician) holds an ownership or investment interest in Meadows or is a party to a compensation arrangement with Meadows. A compensation arrangement is defined broadly to include any arrangement involving any remuneration, directly or indirectly, overtly or covertly, in cash or in kind between a physician (or family member) and a related Meadows entity. Therefore, a financial relationship could be created by a professional services agreement with a physician, the lease of real estate to or from a physician, the provision of free goods or services to a physician, etc.


STARK LAW

The Stark Law defines “immediate family member” broadly to mean a husband or wife; birth or adoptive parent, child or sibling; stepparent, stepchild, stepbrother, or stepsister; father-in-law, mother-in-law, son-in-law, daughter-in-law, brother-in-law, or sister-in-law; grandparent or grandchild; and spouse of a grandparent or grandchild.


STARK LAW

The Stark Law has certain exceptions that allow physicians to enter into financial relationships with Meadows. Some of those exceptions include:The personal services exception to the Stark Law protects fair market value payments to a physician

for legitimate, commercially reasonable and necessary services that are provided pursuant to a service agreement. The service agreement must be in writing, signed by both parties, be a minimum of one year in duration, and must specify compensation that is set in advance.The bona fide employment exception to the Stark Law allows Meadows to employ physicians as long

as their compensation is within fair market value, doesn’t take into account the volume and value of referrals, and is commercially reasonable.Physician services may be provided personally or under the supervision of another physician in the

same group practice as the referring physician.


STARK LAW

MRMC will follow established mechanisms that make possible prompt response to situations where conduct inconsistent with legal requirements or Compliance Program standards or policies and procedures is reported, suspected or confirmed in accordance with MRMC Compliance Program. If a confirmed instance of non- compliance is determined to be a violation that involves solely a probable violation of section 1877 of the Social Security Act, 42 U.S.C§1395nn (the Stark Law) the Compliance Officer in conjunction with General Counsel will disclose such to the Centers for Medicare and Medicaid Services (CMS) through the self-referral disclosure protocol (SRDP).

Stark Law & Anti-Kickback Statue Recent Settlements

Stark Law & Anti-Kickback Statue Recent Settlements United States Joins False Claims Act Lawsuit Against Wheeling Hospital, R & V Associates, and Ronald Violi Based on Improper Payments and Kickbacks to Physicians – December 21, 2018

- The United States has partially intervened in a lawsuit under the False Claims Act against Wheeling Hospital Inc. (Wheeling), R & V Associates Ltd. (R & V), and Ronald Violi in the U.S. District Court for the Western District of Pennsylvania, the Department of Justice announced today. The government intervened with respect to allegations that Wheeling, which is located in Wheeling, WV, violated the Stark Law and Anti-Kickback Statute, and that those violations were caused by R & V, Wheeling’s contracted management consultant, and Violi, Wheeling’s CEO-

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• The Stark Law prohibits a hospital from billing Medicare for services referred by physicians that have an improper financial relationship with the hospital. The Anti-Kickback Statute, in relevant part, prohibits offering or paying anything of value to encourage the referral of items or services covered by federal healthcare programs. The United States alleges that Wheeling’s compensation to a number of employed and contracted physicians violated these statutory prohibitions because that compensation was based on the volume or value of the physicians’ referrals or was above fair market value.

• “Improper financial arrangements between hospitals and physicians threaten patient safety because they can influence the type and amount of health care that is provided,” said Assistant Attorney General Jody Hunt of the Department of Justice’s Civil Division. “The department is committed to taking action to eliminate improper inducements that can corrupt the integrity of physician decision-making.”

• “By bringing allegations of fraud to light, whistleblowers play an important role in protecting the integrity of our healthcare system.” said Scott W. Brady, U.S. Attorney for the Western District of Pennsylvania

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Stark Law & Anti-Kickback Statue Recent SettlementsAmbulance Company and its Municipal Clients Agree to Pay Over $21 Million to Settle Allegations of Unlawful Kickbacks and Improper Financial Relationships – August 27, 2108

• Seven ambulance industry defendants have agreed to pay the government a total of over $21 million to settle a False Claims Act lawsuit alleging that they knowingly submitted claims to the Medicare and Medicaid programs that violated the Anti-Kickback Statute, the Justice Department announced today.

• The Anti-Kickback Statute prohibits offering, paying, soliciting, or receiving remuneration to induce referrals of items or services covered by Medicare, Medicaid, and other federally funded programs. The Anti-Kickback Statute is intended to ensure that medical providers’ judgments are not compromised by improper financial incentives and are instead based on the best interests of their patients.

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Two California Urologist pay $1 Million to Settle False Claims Act Allegations to Radiation Therapy Referrals

January 23, 2018, Drs. Aytac Apaydin and Stephen Worsham, urologists based in Northern California, will pay $1.085 million to resolve allegations that they submitted and caused the submission of false claims to Medicare for image guided radiation therapy (IGRT) that was referred and billed in violation of the physician self-referral law (commonly known as the “Stark Law”) and the Anti-Kickback Statute, the Department of Justice announced. Drs. Apaydin and Worsham own and operate Salinas Valley Urology Associates (SVUA) in Salinas, California. They also owned Advance Radiation Oncology Center (AROC), located in Salinas, California, which dissolved in 2016. IGRT is used to treat patients who are diagnosed with cancer, including prostate cancer patients.

“Health care laws prevent health care providers, and physicians in particular, from referring Medicare services in exchange for financial incentives,” said Acting Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division. “The Department of Justice is committed to enforcing those laws and preventing physicians from improperly injecting profit motives into their decisions about patient care.”

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How do you report a compliance concern?

• Department Management is responsible for approval and tracking of any Vendor Gift•Physicians and/or Providers report invitations to their practice manager for tracking•Individual value of meals should not be greater than $35 • No Department Meals unless approved under a Lunch and Learn provision (Max of 3 per year.)

• We do not accept gifts from vendors that are personal or exorbitant in nature

$35

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Compliance Department

How to access the Meadows Health Compliance & Ethics Website:

Meadows Health - Compliance & Ethics Main Website Link (Click Here)

You have 24/7 access to our new website: meadowshealth.com/compliance-ethics/

From this website you can access the following :– Compliance & Ethics Policy;

– Code of Conduct;

– General Compliance Training Modules; and

– Compliance Hotline Reporting for Concerns

http://meadowshealth.com/compliance-ethics/

COMPLIANCE HOTLINE – DISCLOSURE PROGRAM

www.meadowsregional.ethicspoint.com

1-866-326-6759

“We encourage an environment where open, honest communications are the expectation, not the exception.”

http://www.meadowsregional.ethicspoint.com/

Compliance Department

Compliance Officer - Contact Information

If you have questions or concerns relating to this training or any compliance concern, please feel free to contact:

stark law, anti-kickback statute, arrangements review & … · 2019-05-01 · 3. developing and...

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