CORPORATE INTEGRITY AGREEMENT BETWEEN THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES AND VITAS HOSPICE SERVICES, L.L.C., VITAS HEALTHCARE CORPORATION, VITAS HEALTHCARE CORPORATION OF CALIFORNIA, VITAS HEALTHCARE...

CORPORATE INTEGRITY AGREEMENT
BETWEEN THE
OFFICE OF INSPECTOR GENERAL
OF THE
DEPARTMENT OF HEALTH AND HUMAN SERVICES
AND
VITAS HOSPICE SERVICES, L.L.C., VITAS HEALTHCARE CORPORATION,
VITAS HEALTHCARE CORPORATION OF CALIFORNIA, VITAS
HEALTHCARE CORPORATION OF ILLINOIS, VITAS HEALTHCARE
CORPORATION OF FLORIDA, VITAS HEALTHCARE CORPORATION OF
OHIO, VITAS HEALTHCARE CORPORATION OF ATLANTIC, VITAS
HEALTHCARE OF TEXAS, L.P., VITAS HEALTHCARE CORPORATION
MIDWEST, AND VITAS HEALTHCARE CORPORATION OF GEORGIA.

I.

PREAMBLE

 

VITAS Hospice Services, L.L.C., VITAS Healthcare Corporation, VITAS Healthcare Corporation of California, VITAS Healthcare Corporation of Illinois, VITAS Healthcare Corporation of Florida, VITAS Healthcare Corporation of Ohio, VITAS Healthcare Corporation of Atlantic, VITAS Healthcare of Texas, L.P., VITAS Healthcare Corporation Midwest, and VITAS Healthcare Corporation of Georgia (collectively, "VITAS"), hereby enter into this Corporate Integrity Agreement (CIA) with the Office of Inspector General (OIG) of the United States Department of Health and Human Services (HHS) to promote compliance with the statutes, regulations, and written directives of Medicare, Medicaid, and all other Federal health care programs (as defined in 42 U.S.C. § 1320a-7b(f)) (Federal health care program requirements).  Contemporaneously with this CIA, VITAS is entering into a Settlement Agreement with the United States.

VITAS represents that it has an established corporate compliance program ("Compliance Program"), which preceded the execution of this CIA, and which applies in all aspects to VITAS.  The Compliance Program includes written policies and procedures, education and training programs, ongoing compliance monitoring mechanisms and auditing functions for employees and agents to report incidents of noncompliance in an anonymous and confidential manner, disciplinary actions for individuals violating VITAS' policies and procedures, and oversight by VITAS' Chief Compliance Officer and its Compliance Committee.  VITAS will continue to operate its Compliance Program throughout the term of this CIA, and shall ensure that VITAS complies with each requirement herein.

Vitas Corporate Integrity Agreement

II.	TERM AND SCOPE OF THE CIA

 

Notwithstanding the above, this term does not include part-time or per diem employees, contractors, subcontractors, agents, and other persons who are not reasonably expected to work more than 160 hours during a Reporting Period, except that any such individuals shall become "Covered Persons" at the point when they work more than 160 hours during a Reporting Period.

III.	CORPORATE INTEGRITY OBLIGATIONS

 

VITAS shall establish and maintain a Compliance Program that includes the following elements:

 

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a.	developing and implementing policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and with Federal health care program requirements;

b.

making periodic (at least quarterly) reports regarding compliance matters directly to the Governing Body of VITAS and shall be authorized to report on such matters to the Governing Body at any time.  Written documentation of the Compliance Officer's reports to the Governing Body shall be made available to OIG upon request; and

c.	monitoring the day-to-day compliance activities engaged in by VITAS as well as any reporting obligations created under this CIA.

 

Any noncompliance job responsibilities of the Compliance Officer shall be limited and must not interfere with the Compliance Officer's ability to perform the duties outlined in this CIA.

VITAS shall report to OIG, in writing, any changes in the identity of the Compliance Officer, or any actions or changes that would affect the Compliance Officer's ability to perform the duties necessary to meet the obligations in this CIA, within five days after such a change.

Vitas Corporate Integrity Agreement

VITAS shall report to OIG, in writing, any actions or changes that would affect the Compliance Committee's ability to perform the duties necessary to meet the obligations in this CIA, within 15 days after such a change.

The Governing Body shall, at a minimum, be responsible for the following:

a.	meeting at least quarterly to review and oversee VITAS' compliance program, including but not limited to the performance of the Compliance Officer and Compliance Committee;

b.

submitting to OIG a description of the documents and other materials it reviewed, as well as any additional steps taken, such as the engagement of an independent advisor or other third party resources, in its oversight of the compliance program and in support of making the resolution below during each Reporting Period; and

c.	for each Reporting Period of the CIA, adopting a resolution, signed by each member of the Governing Body summarizing its review and oversight of VITAS' compliance with Federal health care program requirements and the obligations of this CIA.

 

At minimum, the resolution shall include the following language:

"The Governing Body has made a reasonable inquiry into the operations of VITAS' Compliance Program, including the performance of the Compliance Officer and the Compliance Committee.  Based on its inquiry and review, the Governing Body has concluded that, to the best of its knowledge, VITAS has implemented an effective Compliance Program to meet Federal health care program requirements and the obligations of the CIA."

Vitas Corporate Integrity Agreement

If the Governing Body is unable to provide such a conclusion in the resolution, the Governing Body shall include in the resolution a written explanation of the reasons why it is unable to provide the conclusion and the steps it is taking to implement an effective Compliance Program at VITAS.

VITAS shall report to OIG, in writing, any changes in the composition of the Governing Body, or any actions or changes that would affect the Governing Body's ability to perform the duties necessary to meet the obligations in this CIA, within 15 days after such a change.

"I have been trained on and understand the compliance requirements and responsibilities as they relate to [insert name of department], an area under my supervision.  My job responsibilities include ensuring compliance with regard to the [insert name of department] with all applicable Federal health care program requirements, obligations of the Corporate Integrity Agreement, and VITAS policies, and I have taken steps to promote such compliance.  To the best of my knowledge, the [insert name of department] of VITAS is in compliance with all applicable Federal health care program requirements and the obligations of the Corporate Integrity Agreement.  I understand that this certification is being provided to and relied upon by the United States."

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If any Certifying Employee is unable to provide such a certification, the Certifying Employee shall provide a written explanation of the reasons why he or she is unable to provide the certification outlined above.

Within 90 days after the Effective Date, VITAS shall develop and implement a written process for Certifying Employees to follow for the purpose of completing the certification required by this section (e.g., reports that must be reviewed, assessments that must be completed, sub-certifications that must be obtained, etc. prior to the Certifying Employee making the required certification).

"I, [name of Chemed Corporation Executive], have made a reasonable inquiry into the operations of VITAS' Compliance Program, including the performance of the Compliance Officer and the Compliance Committee.  Based on my inquiry and review, the I have concluded that, to the best of my knowledge, VITAS has implemented an effective Compliance Program to meet Federal health care program requirements and the obligations of the CIA."

For the purpose of this paragraph, "Chemed Corporation Executive" means all of the following positions: Chief Executive Officer, and all Executive Vice Presidents, excluding those Executive Vice Presidents who only have responsibilities or obligations related to Roto-Rooter.  If any Chemed Corporation Executive is unable to provide such a certification, the Chemed Corporation Executive shall provide a written explanation of the reasons why he or she is unable to provide the certification outlined above.

Within 90 days after the Effective Date, VITAS shall develop and implement written policies and procedures regarding the operation of its compliance program, including the compliance program requirements outlined in this CIA and VITAS' compliance with Federal health care program requirements (Policies and Procedures).  Throughout the term of this CIA, VITAS shall enforce its Policies and Procedures and shall make compliance with its Policies and Procedures an element of evaluating the performance of all employees.

The Policies and Procedures shall be made available to all Covered Persons.

At least annually (and more frequently, if appropriate), VITAS shall assess and update, as necessary, the Policies and Procedures.  Any new or revised Policies and Procedures shall be made available to all Covered Persons.

All Policies and Procedures shall be made available to OIG upon request.

New members of the Governing Body shall receive the Governing Body Member Training described above within 30 days after becoming a member or within 90 days after the Effective Date, whichever is later.

a.

Engagement of Independent Review Organization.  Within 120 days after the Effective Date, VITAS shall engage an entity (or entities), such as an accounting, auditing, or consulting firm (hereinafter "Independent Review Organization" or "IRO"), to perform the reviews listed in this Section III.D.  The applicable requirements relating to the IRO are outlined in Appendix A to this CIA, which is incorporated by reference.

b.	Retention of Records.  The IRO and VITAS shall retain and make available to OIG, upon request, all work papers, supporting documentation, correspondence, and draft reports (those exchanged between the IRO and VITAS) related to the reviews.

 

Within 90 days after the Effective Date, VITAS shall develop and implement a centralized annual risk assessment and internal review process to identify and address risks associated with VITAS' participation in the Federal health care programs, including but not limited to the risks associated with the submission of claims for items and services furnished to Medicare and Medicaid program beneficiaries.  The risk assessment and internal review process shall require compliance, legal, and department leaders, at least annually, to: (1) identify and prioritize risks, (2) develop internal audit work plans related to the identified risk areas, (3) implement the internal audit work plans, (4) develop corrective action plans in response to the results of any internal audits performed, and (5) track the implementation of the corrective action plans in order to assess the effectiveness of such plans.  VITAS shall maintain the risk assessment and internal review process for the term of the CIA.

Within 90 days after the Effective Date, VITAS shall establish a Disclosure Program that includes a mechanism (e.g., a toll-free compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual's chain of command, any identified issues or questions associated with VITAS' policies, conduct, practices, or procedures with respect to a Federal health care program believed by the individual to be a potential violation of criminal, civil, or administrative law.  VITAS shall appropriately publicize the existence of the disclosure mechanism (e.g., via periodic e-mails to employees or by posting the information in prominent common areas).

The Disclosure Program shall emphasize a nonretribution, nonretaliation policy and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained.  The Disclosure Program also shall include a requirement that all of VITAS' Covered Persons shall be expected to report suspected violations of any Federal health care program requirements to the Compliance Officer or other appropriate individual designated by VITAS.  Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual.  The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that he or she has obtained all of the information necessary to determine whether a further review should be conducted.  For any disclosure that is sufficiently specific so that it reasonably: (1) permits a determination of the appropriateness of the alleged improper practice; and (2) provides an opportunity for taking corrective action, VITAS shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted.

The Compliance Officer (or designee) shall maintain a disclosure log and shall record each disclosure in the disclosure log within two business days of receipt of the disclosure.  The disclosure log shall include a summary of each disclosure received (whether anonymous or not), the status of the respective internal reviews, and any corrective action taken in response to the internal reviews.

a.	an "Ineligible Person" shall include an individual or entity who:

i.	is currently excluded from participation in any Federal health care program; or

ii.	has been convicted of a criminal offense that falls within the scope of 42 U.S.C. § 1320a-7(a), but has not yet been excluded.

b.	"Exclusion List" means the HHS/OIG List of Excluded Individuals/Entities (LEIE) (available through the Internet at ▇▇▇▇://▇▇▇.▇▇▇.▇▇▇.▇▇▇).

 

a.	VITAS shall screen all prospective Covered Persons against the Exclusion List prior to engaging their services and, as part of the hiring or contracting process, shall require such Covered Persons to disclose whether they are Ineligible Persons.

▇.	▇▇▇▇▇ shall screen all current Covered Persons against the Exclusion List within 90 days after the Effective Date and on a monthly basis thereafter.

▇.	▇▇▇▇▇ shall implement a policy requiring all Covered Persons to disclose immediately if they become an Ineligible Person.

 

Nothing in this Section III.G affects VITAS' responsibility to refrain from (and liability for) billing Federal health care programs for items or services furnished, ordered, or prescribed by an excluded person.  VITAS understands that items or services furnished, ordered, or prescribed by excluded persons are not payable by Federal health care programs and that VITAS may be liable for overpayments and/or criminal, civil, and administrative sanctions for employing or contracting with an excluded person regardless of whether VITAS meets the requirements of Section III.G.

Within 30 days after discovery, VITAS shall notify OIG, in writing, of any ongoing investigation or legal proceeding known to VITAS conducted or brought by a governmental entity or its agents involving an allegation that VITAS has committed a crime or has engaged in fraudulent activities.  This notification shall include a description of the allegation, the identity of the investigating or prosecuting agency, and the status of such investigation or legal proceeding.  VITAS also shall provide written notice to OIG within 30 days after the resolution of the matter and a description of the findings and/or results of the investigation or proceeding, if any.

a.	a substantial Overpayment;

b.	a matter that a reasonable person would consider a probable violation of criminal, civil, or administrative laws applicable to any Federal health care program for which penalties or exclusion may be authorized;

c.	the employment of or contracting with a Covered Person who is an Ineligible Person as defined by Section III.G.1.a; or

d.	the filing of a bankruptcy petition by VITAS.

 

A Reportable Event may be the result of an isolated event or a series of occurrences.

 

a.

a complete description of all details relevant to the Reportable Event, including, at a minimum, the types of claims, transactions or other conduct giving rise to the Reportable Event; the period during which the conduct occurred; and the names of individuals and entities believed to be implicated, including an explanation of their roles in the Reportable Event;

b.	a statement of the Federal criminal, civil or administrative laws that are probably violated by the Reportable Event, if any;

c.	the Federal health care programs affected by the Reportable Event;

d.	a description of the steps taken by VITAS to identify and quantify any Overpayments; and

e.	a description of ▇▇▇▇▇' actions taken to correct the Reportable Event and prevent it from recurring.

 

If the Reportable Event involves an Overpayment, within 60 days of identification of the Overpayment, VITAS shall repay the Overpayment, in accordance with the requirements of 42 U.S.C. § 1320a-7k(d) and 42 C.F.R. § 401.301-305 (and any applicable CMS guidance) and provide OIG with a copy of the notification and repayment.

 

IV.	SUCCESSOR LIABILITY

 

In the event that, after the Effective Date, VITAS proposes to (a) sell any or all of its business, business units, or locations (whether through a sale of assets, sale of stock, or other type of transaction) relating to the furnishing of items or services that may be reimbursed by a Federal health care program, or (b) purchase or establish a new business, business unit, or location relating to the furnishing of items or services that may be reimbursed by a Federal health care program, the CIA shall be binding on the purchaser of any business, business unit, or location and any new business, business unit, or location (and all Covered Persons at each new business, business unit, or location) shall be subject to the applicable requirements of this CIA, unless otherwise determined and agreed to in writing by OIG.

If, in advance of a proposed sale or a proposed purchase, VITAS wishes to obtain a determination by OIG that the proposed purchaser or the proposed acquisition will not be subject to the requirements of the CIA, VITAS must notify OIG in writing of the proposed sale or purchase at least 30 days in advance.  This notification shall include a description of the business, business unit, or location to be sold or purchased, a brief description of the terms of the transaction and, in the case of a proposed sale, the name and contact information of the prospective purchaser.

V.	IMPLEMENTATION AND ANNUAL REPORTS

 

Within 120 days after the Effective Date, VITAS shall submit a written report to OIG summarizing the status of its implementation of the requirements of this CIA (Implementation Report).  The Implementation Report shall, at a minimum, include:

VITAS shall submit to OIG a report on its compliance with the CIA requirements for each of the five Reporting Periods (Annual Report).  Each Annual Report shall include, at a minimum, the following information:

 

The first Annual Report shall be received by OIG no later than 90 days after the end of the first Reporting Period.  Subsequent Annual Reports shall be received by OIG no later than the anniversary date of the due date of the first Annual Report.

a.	to the best of his or her knowledge, except as otherwise described in the report, VITAS has implemented and is in compliance with all of the requirements of this CIA; and

b.	he or she has reviewed the report and has made reasonable inquiry regarding its content and believes that the information in the report is accurate and truthful.

 

3.            Chief Financial Officer.  The first Annual Report shall include a certification by the Chief Financial Officer that, to the best of his or her knowledge, VITAS has complied with its obligations under the Settlement Agreement: (a) not to resubmit to any Federal health care program payors any previously denied claims related to the Covered Conduct addressed in the Settlement Agreement, and not to appeal any such denials of claims; (b) not to charge to or otherwise seek payment from federal or state payors for unallowable costs (as defined in the Settlement Agreement); and (c) to identify and adjust any past charges or claims for unallowable costs.

VITAS shall clearly identify any portions of its submissions that it believes are trade secrets, or information that is commercial or financial and privileged or confidential, and therefore potentially exempt from disclosure under the Freedom of Information Act (FOIA), 5 U.S.C. § 552.  VITAS shall refrain from identifying any information as exempt from disclosure if that information does not meet the criteria for exemption from disclosure under FOIA.

VI.	NOTIFICATIONS AND SUBMISSION OF REPORTS

 

Unless otherwise stated in writing after the Effective Date, all notifications and reports required under this CIA shall be submitted to the following entities:

	OIG:
	Administrative and Civil Remedies Branch
	Office of Counsel to the Inspector General
	Office of Inspector General
	U.S. Department of Health and Human Services
	▇▇▇▇▇ Building, Room 5527
	▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇.▇.
	Washington, DC 20201
	Telephone: ▇▇▇.▇▇▇.▇▇▇▇
	Facsimile: 202.205.0604
	VITAS:
	▇▇▇ ▇▇▇▇▇▇, VITAS Chief Compliance Officer
	2600 Chemed Center
	▇▇▇ ▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇
	Cincinnati, Ohio 45202
	Telephone: ▇▇▇-▇▇▇-▇▇▇▇

 

Unless otherwise specified, all notifications and reports required by this CIA shall be made by electronic mail, overnight mail, hand delivery, or other means, provided that there is proof that such notification was received.  Upon request by OIG, VITAS may be required to provide OIG with an electronic copy of each notification or report required by this CIA in addition to a paper copy.

VII.	OIG INSPECTION, AUDIT, AND REVIEW RIGHTS

 

In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine and/or request copies of or copy VITAS' books, records, and other documents and supporting materials, and conduct on-site reviews of any of VITAS' locations, for the purpose of verifying and evaluating: (a) VITAS' compliance with the terms of this CIA and (b) VITAS' compliance with the requirements of the Federal health care programs.  The documentation described above shall be made available by VITAS to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or reproduction.  Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview any of VITAS' owners who are natural persons (other than shareholders who: (1) have an ownership interest of less than 5% and (2) acquired the ownership interest through public trading), employees, contractors, and directors who consent to be interviewed at the individual's place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG.  VITAS shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG's request.  VITAS' owners, employees, contractors, and directors may elect to be interviewed with or without a representative of VITAS present.

VIII.

DOCUMENT AND RECORD RETENTION

 

VITAS shall maintain for inspection all documents and records relating to reimbursement from the Federal health care programs and to compliance with this CIA for six years (or longer if otherwise required by law) from the Effective Date.

IX.	DISCLOSURES

 

Consistent with HHS's FOIA procedures, set forth in 45 C.F.R. Part 5, OIG shall make a reasonable effort to notify VITAS prior to any release by OIG of information submitted by VITAS pursuant to its obligations under this CIA and identified upon submission by VITAS as trade secrets, or information that is commercial or financial and privileged or confidential, under the FOIA rules.  With respect to such releases, VITAS shall have the rights set forth at 45 C.F.R. § 5.65(d).

 

X.	BREACH AND DEFAULT PROVISIONS

 

VITAS is expected to fully and timely comply with all of its CIA obligations.

As a contractual remedy, VITAS and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as "Stipulated Penalties") in accordance with the following provisions.

a.	a Compliance Officer;

b.	a Compliance Committee;

c.	the Governing Body compliance obligations;

d.	the management certification obligations;

e.	written Policies and Procedures;

f.	training and education of Covered Persons and Governing Body Members;

g.	a risk assessment and internal review process;

h.	a Disclosure Program;

i.	Ineligible Persons screening and removal requirements;

j.	notification of Government investigations or legal proceedings;

k.	policies and procedures regarding the repayment of Overpayments; and

l.	reporting of Reportable Events.

 

 

VITAS may, in advance of the due date, submit a timely written request for an extension of time to perform any act or file any notification or report required by this CIA.  Notwithstanding any other provision in this Section, if OIG grants the timely written request with respect to an act, notification, or report, Stipulated Penalties for failure to perform the act or file the notification or report shall not begin to accrue until one day after VITAS fails to meet the revised deadline set by OIG.  Notwithstanding any other provision in this Section, if OIG denies such a timely written request, Stipulated Penalties for failure to perform the act or file the notification or report shall not begin to accrue until three days after VITAS receives OIG's written denial of such request or the original due date, whichever is later.  A "timely written request" is defined as a request in writing received by OIG at least five days prior to the date by which any act is due to be performed or any notification or report is due to be filed.

4.            Independence from Material Breach Determination.  Except as set forth in Section X.D.1.c, these provisions for payment of Stipulated Penalties shall not affect or otherwise set a standard for OIG's decision that VITAS has materially breached this CIA, which decision shall be made at OIG's discretion and shall be governed by the provisions in Section X.D, below.

 

a.	repeated violations or a flagrant violation of any of the obligations under this CIA, including, but not limited to, the obligations addressed in Section X.A;

b.	a failure by VITAS to report a Reportable Event, take corrective action, or make the appropriate refunds, as required in Section III.J;

c.	a failure to respond to a Demand Letter concerning the payment of Stipulated Penalties in accordance with Section X.C; or

d.	a failure to engage and use an IRO in accordance with Section III.D, Appendix A, or Appendix B.

 

a.	the alleged material breach has been cured; or

b.	the alleged material breach cannot be cured within the 30 day period, but that: (i) VITAS has begun to take action to cure the material breach; (ii) VITAS is pursuing such action with due diligence; and (iii) VITAS has provided to OIG a reasonable timetable for curing the material breach.

 

 

2.            Stipulated Penalties Review.  Notwithstanding any provision of Title 42 of the United States Code or Title 42 of the Code of Federal Regulations, the only issues in a proceeding for Stipulated Penalties under this CIA shall be: (a) whether VITAS was in full and timely compliance with the obligations of this CIA for which OIG demands payment; and (b) the period of noncompliance.  VITAS shall have the burden of proving its full and timely compliance and the steps taken to cure the noncompliance, if any.  OIG shall not have the right to appeal to the DAB an adverse ALJ decision related to Stipulated Penalties.  If the ALJ agrees with OIG with regard to a finding of a breach of this CIA and orders VITAS to pay Stipulated Penalties, such Stipulated Penalties shall become due and payable 20 days after the ALJ issues such a decision unless VITAS requests review of the ALJ decision by the DAB.  If the ALJ decision is properly appealed to the DAB and the DAB upholds the determination of OIG, the Stipulated Penalties shall become due and payable 20 days after the DAB issues its decision.

 

 

a.	VITAS cured such breach within 30 days of its receipt of the Notice of Material Breach; or

b.

the alleged material breach could not have been cured within the 30 day period, but that, during the 30 day period following VITAS' receipt of the Notice of Material Breach: (i) VITAS had begun to take action to cure the material breach; (ii) VITAS pursued such action with due diligence; and (iii) VITAS provided to OIG a reasonable timetable for curing the material breach.

 

For purposes of the exclusion herein, exclusion shall take effect only after an ALJ decision favorable to OIG, or, if the ALJ rules for VITAS, only after a DAB decision in favor of OIG.  VITAS' election of its contractual right to appeal to the DAB shall not abrogate OIG's authority to exclude VITAS upon the issuance of an ALJ's decision in favor of OIG.  If the ALJ sustains the determination of OIG and determines that exclusion is authorized, such exclusion shall take effect 20 days after the ALJ issues such a decision, notwithstanding that VITAS may request review of the ALJ decision by the DAB.  If the DAB finds in favor of OIG after an ALJ decision adverse to OIG, the exclusion shall take effect 20 days after the DAB decision.  VITAS shall waive its right to any notice of such an exclusion if a decision upholding the exclusion is rendered by the ALJ or DAB.  If the DAB finds in favor of VITAS, VITAS shall be reinstated effective on the date of the original exclusion.

 

XI.	EFFECTIVE AND BINDING AGREEMENT

 

▇▇▇▇▇ and OIG agree as follows:

 

 

	ON BEHALF OF CHEMED
/s/ ▇▇▇▇ ▇▇▇▇▇▇▇▇		10-27-17
▇▇▇▇ ▇▇▇▇▇▇▇▇		DATE
Executive Vice President
Chemed Corporation
/s/ ▇▇▇▇▇ ▇▇▇▇▇▇▇		10-27-17
▇▇▇▇▇ ▇▇▇▇▇▇▇		DATE
▇▇▇▇▇ Lovells US, LLP
Counsel for Chemed Corporation
	ON BEHALF OF VITAS
/s/ ▇▇▇▇ ▇▇▇▇▇▇▇▇		10-27-17
▇▇▇▇ ▇▇▇▇▇▇▇▇		DATE
Executive Vice President
Chemed Corporation
/s/ ▇▇▇▇▇ ▇▇▇▇▇▇▇		10-27-17
▇▇▇▇▇ ▇▇▇▇▇▇▇		DATE
▇▇▇▇▇ Lovells US, LLP
Counsel for Chemed Corporation

 

 

	ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES
/s/ ▇▇▇▇ ▇. Re		10/30/17
▇▇▇▇ ▇. RE		DATE
Assistant Inspector General for Legal Affairs
Office of Inspector General
U.S. Department of Health and Human Services
/s/ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇		10/30/17
▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇		DATE
Senior Counsel
Office of Inspector General
U.S. Department of Health and Human Services
/s/ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇		10/30/17
▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇		DATE
Senior Counsel
Office of Inspector General
U.S. Department of Health and Human Services

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APPENDIX A

INDEPENDENT REVIEW ORGANIZATION

This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.D of the CIA.

A.	IRO Engagement

 

B.	IRO Qualifications

 

The IRO shall:

4.            assign licensed nurses or physicians with relevant education, training and specialized expertise (or other licensed health care professionals acting within their scope of practice and specialized expertise) to make the medical necessity determinations required by the Claims Review; and

 

Vitas CIA – Appendix A

C.	IRO Responsibilities

 

The IRO shall:

D.	IRO Independence and Objectivity

 

The IRO must perform the Claims Review in a professionally independent and objective fashion, as defined in the most recent Government Auditing Standards issued by the U.S. Government Accountability Office.

E.	IRO Removal/Termination

 

 

Vitas CIA – Appendix A

 

 

 

 

APPENDIX B

CLAIMS REVIEW

 

 

Vitas CIA – Appendix B

 

 

 

 

 

 

 

a.

Eligibility Review. The IRO shall select a Beneficiary Sample. For each Medicare beneficiary in the Beneficiary Sample, the IRO shall randomly select a Claim Period to be reviewed (Selected Claim Period). The IRO shall review the medical records of each Medicare beneficiary in the Beneficiary Sample based on the supporting documentation available at VITAS's offices or under VITAS's control and applicable billing and coding regulations and guidance to determine whether the beneficiary was eligible for hospice services for the Selected Claim Period.   For any beneficiary in the Beneficiary Sample that results in a determination by the IRO that the beneficiary was not eligible for the hospice benefit during the Selected Claim Period, the IRO shall review all claims for hospice services billed by VITAS for that beneficiary to determine whether the beneficiary was eligible for hospice services. The IRO shall submit a supplemental report no later than 90 days after the IRO completes its report. VITAS shall refund any Overpayments identified as a result of this additional review and documentation of the refund of any identified Overpayments shall be made available to OIG upon request.   Additionally, the IRO shall perform a review of the system(s) and process(es) that resulted in VITAS's erroneous determination that the beneficiary was eligible for the hospice benefit, to identify any problems or weaknesses that may have resulted in the identified error(s). The IRO shall provide its observations and recommendations on suggested improvements to the system(s) and the process(es) for determining eligibility for the hospice benefit.

 

 

b.

Appropriate Level of Services Review.  The Appropriate Level of Services Review shall consist of a review to ensure that the medical record supports the appropriateness of the Level of Services billed during the Selected Claim Period and that the claim was properly submitted to and reimbursed by Medicare.  This review shall be completed for each beneficiary in the Beneficiary Sample who was determined to be eligible for hospice services during the Selected Claim Period.  The IRO shall review medical records for the Medicare beneficiaries selected based on the supporting documentation available at VITAS's offices or under VITAS's control and applicable billing and coding regulations and guidance to determine the appropriateness of the Level of Services billed and reimbursed.

 

 

 

For any beneficiary in the Beneficiary Sample that results in a determination by the IRO that the Level of Services billed was not appropriate, the IRO shall review all claims for hospice services for that beneficiary where the Level of Services billed was above Routine Home Care.  The IRO shall submit a supplemental report no later than 90 days after the IRO completes its report.  VITAS shall refund any Overpayments identified as a result of this additional review and documentation of the refund of any identified Overpayments shall be made available to OIG upon request.

Additionally, the IRO shall perform a review of the system(s) and process(es) that resulted in VITAS's erroneous determination that medical necessity existed for the Level of Services billed, to identify any problems or weaknesses that may have resulted in the identified error(s).  The IRO shall provide its observations and recommendations on suggested improvements to the system(s) and the process(es) for determining medical necessity for the Level of Services provided.

a.

Supplemental Materials.  The IRO shall request all documentation and materials required for its review of the medical records of the Medicare beneficiaries selected as part of each Beneficiary Sample and VITAS shall furnish such documentation and materials to the IRO prior to the IRO initiating its review of each Beneficiary Sample.  If the IRO accepts any supplemental documentation or materials from VITAS after the IRO has completed its initial review of any Beneficiary Sample (Supplemental Materials), the IRO shall identify in the Claims Review Report the Supplemental Materials, the date the Supplemental Materials were accepted, and the relative weight the IRO gave to the Supplemental Materials in its review.  In addition, the IRO shall include a narrative in the Claims Review Report describing the process by which the Supplemental Materials were accepted and the IRO's reasons for accepting the Supplemental Materials.

b.

Claims without Supporting Documentation.  If VITAS cannot produce documentation for the Selected Claim Period for any beneficiary selected as part of any Beneficiary Sample, then the total reimbursement received by VITAS for hospice services furnished to such beneficiary during the Selected Claim Period shall be deemed an Overpayment. Replacement sampling for Medicare beneficiaries with missing documentation is not permitted.

 

 

 

Vitas CIA – Appendix B

c.	Use of First Samples Drawn.  For the purposes of all samples discussed in this Appendix, the Medicare beneficiaries selected in each first sample shall be used (i.e., it is not permissible to generate more than one list of random samples and then select one for use with a Beneficiary Sample).

 

 

a.	Review Population.  A description of the Beneficiary Population .

b.	Review Objective.  A clear statement of the objective intended to be achieved by the Eligibility Review and the Appropriate Level of Services Review.

c.	Source of Data.  A description of (1) the process used to identify the beneficiaries in each Beneficiary Population and (2) the specific documentation relied upon by the IRO when performing the Eligibility Review and the Appropriate Level of Services Review.

 

 

 

Vitas CIA – Appendix B

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d.	Review Protocol.  A narrative description of how the Eligibility Review and the Appropriate Level of Services Review were conducted and what was evaluated.

e.	Supplemental Materials.  A description of any Supplemental Materials as required by A.4.a., above.

 

a.	A copy of the printout of the random numbers generated by the "Random Numbers" function of the statistical sampling software used by the IRO.

b.	A description or identification of the statistical sampling software package used to select the samples described in this Appendix.

 

 

a.	Narrative Results.

i.	A description of VITAS's hospice eligibility certification, recertification, and determination of appropriate Level of Service processes, including the identification, by position description, of the personnel involved.

ii.	A narrative explanation of the IRO's findings and supporting rationale (including reasons for errors, patterns noted, concerns relating to the eligibility for hospice or appropriateness of hospice services, etc.) regarding the Eligibility Review and the Appropriate Level of Services Review.

b.	Quantitative Results.

i.

Total number and percentage of instances in which the IRO determined that the documentation for a Medicare beneficiary did not support that the beneficiary was eligible for the Medicare hospice benefit or did not support that the beneficiary received the appropriate Level of Services based on medical necessity, regardless of the effect on the payment.