. I MPLEMENTING A S UCCESSFUL C OMPLIANCE P ROGRAM Presented by Jeffrey S. Baird, Esq. © 2015 Brown...

.

IMPLEMENTING A SUCCESSFUL

COMPLIANCE PROGRAM

Presented by

Jeffrey S. Baird, Esq.

© 2015 Brown & Fortunato, P.C.

Introduction

• The HME industry is young.• The industry grew up relatively unregulated.• Another challenge is that few people with

CMS and on Capitol Hill have ever set foot in an HME company.

• As the government is famous for doing, it overreacted.

Introduction

• The pendulum will eventually swing back towards the middle.

• Until that time, however, the HME industry will have to deal with intrusive government scrutiny.

• The demand for what the industry has to offer will only increase exponentially.

Introduction

• There are 78 million baby boomers.• The “irresistible force” (demand) meets the

“immovable object” (reduced reimbursement).

• And so while we are in strange times, the future is bright for well-run, innovative HME providers.

Introduction

• It is crucial that the HME supplier understand and comply with payment and coverage policies and comply with the many anti-fraud laws.

Challenge to the Supplier

• A challenge for the HME provider are the inquiries and investigations being conducted by DME MACs, RACs, CERTs, ZPICs, the NSC, and accrediting organizations.


• DME MACs, and particularly ZPICs, are aggressively conducting prepayment reviews and post-payment audits.

• The accrediting organizations (“AOs”) are being required by CMS to ask probing questions and report to CMS and the NSC any activities that the AOs believe are improper.


• The ZPICs are directing DME MACs to suspend payments when the ZPICs conclude that improper activities are occurring.

• In response to reports from the ZPICs, the NSC is suspending/revoking supplier numbers.


• When conducting post-payment audits, the DME MACs and ZPICs are asking questions that go far beyond whether the provider has complete and accurate documentation.

• The NSC is aggressively conducting unannounced on-site inspections; in so doing, the NSC inspectors are asking questions that go beyond the rudimentary questions that have been posed in the past.

The Patient Protection and Affordable Care Act

The Patient Protection and Affordable Care Act

• The Senate Health Reform Bill, H.R. 3590, entitled the “Patient Protection and Affordable Care Act” (PPACA), was passed by the U.S. Senate on December 24, 2009.

• The House of Representatives passed the Senate Bill on March 22, 2010, and the President signed it into law on March 23, 2010.

• The following is a discussion of some of the PPACA’s provisions that are relevant to HME providers.

PPACA ProvisionsSec. 6401 - Provider Screening

• Providers enrolling or re-enrolling in Medicare, Medicaid, or CHIP will be subject to screening measures.

• The Secretary is required to determine the level of screening according to the risk of fraud, waste, and abuse with respect to each category of provider.


• All providers will be subject to licensure checks and, if the Secretary so determines, additional screening measures, such as criminal background checks, fingerprinting, database checks, and unscheduled and unannounced site visits.

• The government is moving away from “pay and chase” to “guarding the henhouse.”


• The HME and home health industries are experiencing unannounced site visits from a variety of sources: − the NSC− the OIG− a state Medicaid program− an accrediting organization or− a Medicare contractor

PPACA ProvisionsSec. 6401 – Disclosure Requirements

• Providers enrolling or re-enrolling in Medicare, Medicaid, or CHIP will be subject to new disclosure requirements.


• Applicants will be required to disclose current or previous affiliations, directly or indirectly, with any provider that has uncollected debt, been subject to payment suspension under a federal health care program, has been excluded from participating in a Federal health care program, or has had its billing privileges denied or revoked.


• The Secretary may deny enrollment or re-enrollment if such affiliations pose an undue risk of fraud, waste, or abuse.

PPACA ProvisionsSec. 6401 – Offset Payments*

• The Secretary may adjust payments to a provider that has the same tax ID number as a provider that owes past-due obligations under Medicare, Medicaid, or CHIP, regardless of such provider’s Medicare billing number or NPI.

*From Providers with Same Tax ID Number

PPACA ProvisionsSec. 6401 – Temporary Moratorium

• The Secretary may impose a temporary moratorium on the enrollment of new providers if the Secretary determines that such action is necessary to prevent or combat fraud, waste, or abuse.

PPACA ProvisionsSec. 6401 – Compliance Programs

• By a date determined by the Secretary, certain providers will be required to establish a compliance program.

• Such compliance program must contain core elements, which will be established by the Secretary in consultation with the OIG.

PPACA ProvisionsSec. 6402 – Medicare and Medicaid*

Reporting and Returning Overpayments

• Any provider that receives an overpayment must

(i) report the overpayment to the Secretary, carrier, or other appropriate person and

(ii) provide written notice of the reason for the overpayment.

*Enhanced Medicare and Medicaid Program Integrity Provisions


Reporting and Returning Overpayments

• An overpayment must be reported and returned no later than 60 days after it is identified or the date of any corresponding cost report (if applicable).

• Failure to do so may result in civil money penalties.



Anti-kickback Statute and False Claims Act

• A claim that includes items or services resulting from a violation of the Medicare/Medicaid anti-kickback statute constitutes a false or fraudulent claim under the Civil False Claims Act (31 USC § 3729).


PPACA ProvisionsSec. 6411 – RAC Program

Expansion of the Recovery Audit Contractor (RAC) Program

• States must establish contracts with one or more RACs for the purpose of identifying underpayments and overpayments and recouping overpayments under the state Medicaid plan or any waiver of the state plan.

Steps to Reduce the Risk of Being Subjected to an Enforcement Action

Effective Corporate Compliance Program

• The OIG stresses the importance of compliance programs by issuing guidance to various provider and supplier types concerning the implementation of compliance programs.

Why Implement a Compliance Program

• A very simple answer to this question can be found by reading the quality standards for suppliers of durable medical equipment, prosthetics or products and supplies issued on August 14, 2006.


• According to the final quality standards, the supplier shall implement business practices to prevent and control fraud, waste and abuse by:− Using procedures that articulate standards of

conduct to ensure the organization’s compliance with applicable laws and regulations; and

− Designating one or more individuals in leadership position to address compliance issues.


• The following are reasons that DME suppliers should implement corporate compliance programs…

Ten Reasons to Implement aCompliance Program

1- Adopting a compliance program concretely demonstrates to the community at large that a provider has a strong commitment to honesty and responsible corporate citizenship.

2- Compliance programs reinforce employees’ innate sense of right and wrong.


3- An effective compliance program helps a provider fulfill its legal duty to government and private payors.

4- Compliance programs are cost effective.


5- A compliance program provides a more accurate view of employee and contractor behavior relating to fraud and abuse.

6- The quality of care provided to patients is enhanced by an effective compliance program.


7- A compliance program provides procedures to promptly correct misconduct .

8- An effective compliance program may mitigate any sanction imposed by the government.


9- Voluntarily implementing a compliance program is preferable to waiting for the OIG to impose a corporate integrity agreement.

10- Effective corporate compliance programs may protect corporate directors from personal liability.

Compliance Obstacles

• Following are ten obstacles that suppliers may face in implementing effective compliance programs…

Ten Obstacles in Implementing aCompliance Program

1- Creating buy-in and enthusiasm

2- Changing past behavior

3- Lack of or poor communication

4- Too many roles for compliance officer

5- Not enough financial support

Ten Obstacles in Implementing aCompliance Program

6- Integrating compliance with other systems

7- Overcoming fear of retaliation/retribution

8- Finding qualified people

9- Lack of procedures

10- Education and training

How a Corporate Compliance Program Should Be Structured

Seven Required Elements of OIG Compliance Guidelines

The OIG’s compliance guidelines for DME suppliers lists seven required elements of an effective compliance program.

1. Written Policies and Procedures

2. Designation of a Compliance Officer and Compliance Committee

3. Conducting Effective Training and Education

Seven Required Elements of OIG Compliance Guidelines

4. Developing Effective Lines of Communication

5. Enforcement of Disciplinary Standards

6. Auditing and Monitoring

7. Response to Offenses and Corrective Action

Identifying Risk Areas

• It is not enough for suppliers to implement policies and procedures generally geared at educating staff and identifying potential regulatory and statutory violations.

• The organization is required to implement policies and procedures targeted at specific risk areas of concern to the individual company.

Compliance Program Follow-Up

• Once the corporate compliance program is implemented, the supplier must continue to take steps on an on-going basis to ensure that the plan remains effective.

Table of Contents

I. CODE OF CONDUCT/INTRODUCTIONA. Relationships with Physicians and Others in a

Position to Influence Our Business1. Stark Law

2. Anti-Kickback Law

3. False Claims Laws

4. Civil Money Penalty Law

5. Contracts and Contract Administration

6. Referrals to Other Providers

Table of Contents

B. Inappropriate Relationships Between and Among Employees and/or Patients

C. Conflicts of Interest1. In General

2. Prior Approval for Potential Conflicts

D. Receipt of Improper Payments or Gifts

E. Use of ABC Medical Funds for Improper Payments or Gifts

Table of Contents

F. Honesty in Business Dealings

G. Confidentiality

H. Employment Practices

I. Reporting Abuse

J. Quality of Care

K. Physician Orders and Certificates of Medical Necessity

L. Billing Practices

M. Medical Documentation

Table of Contents

N. ABC Medical Property1. Propriety Information

2. Use of At Home Medical Property

O. At Home Medical Organizational and Financial Records

1. General Information

2. Transaction Records

3. Audit Procedure

Table of Contents

P. Licenses, Permits and Certifications

Q. Marketing

R. Document Retention

S. Education and Training

T. Investigations and Corrective Action

U. Program Monitoring and Auditing

Table of Contents

II. ENFORCEMENT AND DISCIPLINEA. Persons Subject to Action

B. Consideration

C. Legal Actions

III. COMPLIANCE PROGRAM OPERATIONA. Compliance Officer

B. Compliance Committee

C. Officer Reports

Table of Contents

IV. POLICIESA. Certificate of Medical Necessity

B. Claim Review

C. Compliance Training

D. Conflict of Interest

E. Employee Screening

F. Enforcement

G. False Statements

Table of Contents

H. Marketing Expense Budget and Gift Policy1. Marketing Mission Statement and Underlying Law

2. Marketing Expense Budget

3. Gifts to Individuals Who Are Not Physicians or Patients

4. Gifts to Physicians

5. Gifts to Patients

6. Gift Certificates/Cash Equivalents

7. Disciplinary Guidelines

Table of Contents

I. HCPCS Coding

J. Inexpensive or Other Routinely Purchased DME Items and Capped Rental Items

K. Internal Reporting

L. Investigations

M. KX Modifier

N. Medical Necessity

O. Medicare Assignment

Table of Contents

P. Payment Likely to Be Denied

Q. Physician Orders

R. Plan Auditing

S. Refusing to Submit a Claim to Medicare

T. Routine Waiver of Deductibles and Coinsurance

U. Wiretapping

Table of Contents

V. FormsA. Stark Law Compliance Checklist

B. Supervisor’s Compliance Certificate

C. Employee’s Compliance Certificate

D. Compliance Report Form

E. Document Retention Schedule

Compliance Manual Summary

• Code of Conduct− Stark− Medicare/Medicaid – Anti-Kickback Statute− False Claims Laws− Civil Monetary Penalties− Contracts− Referrals to Other Providers− Inappropriate Relationships with Patients


• Code of Conduct− Conflict of Interest

In General Prior Approval for Potential Conflicts Examples

− Improper Payments− Confidentiality − Employment Practices


• Code of Conduct− Reporting Abuse− Quality of Care− Physician Orders and Certificates of Medical

Necessity− Medical Record Documentation− Company Property and Proprietary

Information− Corporate and Financial Records


• Code of Conduct− Marketing− Document Retention− Education and Training− Duties of Compliance Officer

• Enforcement and Discipline− Reporting− Persons Subject to Action− Consideration


• Compliance Program Operation− Compliance Officer− Corporate Compliance Committee− Officer Report

• Additional Policies− Auditing − Background Screening − Claim Review


• Additional Policies (continued)

− HCPCS − Telephone Solicitation− Advance Beneficiary Notice (“ABN”)

Marketing Expense Budgetand Gift Policy

• Marketing Mission Statement and Underlying Law

• Marketing Expense Budget• Gifts to Individuals Who Are Not

Physicians or Patients• Gifts to Physicians (Gifts to physicians who are also

patients must meet the requirements of Sections D and E)

Marketing Expense Budgetand Gift Policy

• Gifts to Patients (Gifts to patients who are also physicians must meet the requirements of Sections D and E)

• Gift Certificates/Cash Equivalents• Disciplinary Guidelines

Self Audits

Why Perform a Self-Audit?

• One of the primary advantages, if the One of the primary advantages, if the supplier has a corporate compliance supplier has a corporate compliance program, is to provide evidence that the program, is to provide evidence that the corporate compliance program is corporate compliance program is effective. effective.

• This is important because an effective This is important because an effective corporate compliance program can corporate compliance program can greatly reduce any fines or penalties that greatly reduce any fines or penalties that might result from a government might result from a government investigation.investigation.

Why Perform a Self-Audit?

• An effective corporate compliance An effective corporate compliance program may also result in the program may also result in the government not requiring the supplier to government not requiring the supplier to enter into a corporate integrity agreement enter into a corporate integrity agreement as part of a settlement resulting from an as part of a settlement resulting from an investigation.investigation.

Hallmarks of Effective Self-Audits

RoutineRoutine

• An effective internal audit process will An effective internal audit process will become part of what the supplier does. become part of what the supplier does.


PeriodicPeriodic

• An effective audit procedure takes place An effective audit procedure takes place periodically. periodically.

• The exact period does not matter so The exact period does not matter so much as that an audit happens at defined much as that an audit happens at defined time intervals. time intervals.


PeriodicPeriodic

• Also, note that how often self-audits occur Also, note that how often self-audits occur is influenced by and, in turn, influences is influenced by and, in turn, influences the scope of the audit. the scope of the audit.


Eventually cover all areas of exposureEventually cover all areas of exposure

• Whether the audits are monthly, Whether the audits are monthly, quarterly, or annually, the audits should quarterly, or annually, the audits should address all risk areas for the supplier. address all risk areas for the supplier.


Individuals held accountableIndividuals held accountable

• Individuals should be held accountable Individuals should be held accountable both for the performance of the audits both for the performance of the audits and for implementing any changes that and for implementing any changes that result from the audits. result from the audits.


Documentation of the auditDocumentation of the audit

• Proper documentation of the audit must Proper documentation of the audit must be maintained and the documentation be maintained and the documentation must include the following:must include the following:– the specific risk areas the audit addressedthe specific risk areas the audit addressed– the individuals performing the auditthe individuals performing the audit– the time frame of the auditthe time frame of the audit


• Proper documentation (continued):Proper documentation (continued):– a copy of the audit toola copy of the audit tool– the results of the auditthe results of the audit– recommendations for changes to policies recommendations for changes to policies

and proceduresand procedures


• Proper documentation (continued):Proper documentation (continued):– specific changes that were, in fact, specific changes that were, in fact,

implemented as a result of the auditimplemented as a result of the audit– a subsequent re-audit to verify that the a subsequent re-audit to verify that the

changes in policies and procedures took changes in policies and procedures took rootroot

Specific Self-Audit Areas and Procedures

• Review denials received from the MACs Review denials received from the MACs to determine if there are any patterns to to determine if there are any patterns to the denials. the denials.

• Review the supplier's accounts Review the supplier's accounts receivable history. receivable history.

• Review the OIG's annual workplan. Review the OIG's annual workplan.


• Review recent reports published by Review recent reports published by various HHS departments. various HHS departments. – Reports on abuses in the marketing of Reports on abuses in the marketing of

diabetes testing supplies should have diabetes testing supplies should have prompted suppliers providing diabetes prompted suppliers providing diabetes testing supplies to review and evaluate testing supplies to review and evaluate their marketing practices.their marketing practices.


• Review the results of Medicare hearings, Review the results of Medicare hearings, appeals, and reviews. appeals, and reviews. – These will often pinpoint, with laser-These will often pinpoint, with laser-

like specificity, any problems in the like specificity, any problems in the supplier’s underlying medical supplier’s underlying medical necessity documentation.necessity documentation.


• Upon hiring new individuals, and at least Upon hiring new individuals, and at least once per year thereafter, verify that the once per year thereafter, verify that the individual does not appear on the OIG's individual does not appear on the OIG's list of excluded individuals.list of excluded individuals.

• Test various employees (especially Test various employees (especially billing personnel) to verify their billing personnel) to verify their knowledge of correct procedures.knowledge of correct procedures.


• Review the size and age of the supplier’s Review the size and age of the supplier’s credit balances.credit balances.

• Review the OIG's Corporate Compliance Review the OIG's Corporate Compliance Program Guidance for DME Suppliers.Program Guidance for DME Suppliers.

• Review the audits conducted and Review the audits conducted and develop statistics. develop statistics.

Post-Audit Follow-Up

• The audit summary should be reported to The audit summary should be reported to the supplier’s president on a routine basis.the supplier’s president on a routine basis.


Other follow-up actions may include, but are Other follow-up actions may include, but are not limited to:not limited to:•Revising policies and procedures. This can Revising policies and procedures. This can be helpful in correcting systemic errors. be helpful in correcting systemic errors. •Providing additional training in specific Providing additional training in specific areas. areas. •Making refunds, if appropriate. Making refunds, if appropriate. •Taking disciplinary action, if necessary.Taking disciplinary action, if necessary.


Other follow-up actions (continued):Other follow-up actions (continued):

• Changing the focus of the audits. Changing the focus of the audits. – Audit plans should be flexible and Audit plans should be flexible and

revised based upon the results of revised based upon the results of previous audits. previous audits.

– There is no magic formula for how There is no magic formula for how many internal audits must be many internal audits must be conducted and what each audit should conducted and what each audit should contain. contain.


Other follow-up actions (continued):Other follow-up actions (continued):

• Documenting specific changes that were, Documenting specific changes that were, in fact, implemented as a result of the in fact, implemented as a result of the audit, and subsequent re-audits to verify audit, and subsequent re-audits to verify that the changes in policies and that the changes in policies and procedures and that corrective actions procedures and that corrective actions have been implemented successfully.have been implemented successfully.


• All audit plans, audit summaries and All audit plans, audit summaries and completed audit tools should be completed audit tools should be maintained and secured in an organized maintained and secured in an organized manner .manner .

• The supplier should also review its denials The supplier should also review its denials received from the MACs and other payor received from the MACs and other payor sources to determine if there are any sources to determine if there are any patterns to the denials. patterns to the denials.


• The accounts receivable history, hardship The accounts receivable history, hardship waivers, co-payments and deductible waivers, co-payments and deductible payments and usage of the KX modifier payments and usage of the KX modifier are items that should be reviewed during are items that should be reviewed during audits. audits.

• The supplier should become familiar with The supplier should become familiar with the major investigative targets.the major investigative targets.


• Key sources of information on “hot” Key sources of information on “hot” targets include the annual work plan targets include the annual work plan from the OIG, fraud alerts issued by the from the OIG, fraud alerts issued by the OIG, and focused medical reviews OIG, and focused medical reviews described in payors’ provider bulletins.described in payors’ provider bulletins.

Preparing for a Government Investigation

Introduction

• Assume that a DME company suspects Assume that a DME company suspects it is under investigation. it is under investigation.

• Perhaps the clues were a series of Perhaps the clues were a series of particularly detailed or expansive particularly detailed or expansive documentation requests or audits. documentation requests or audits.

Introduction

• Or perhaps referring physicians reported Or perhaps referring physicians reported receiving telephone calls from Medicare receiving telephone calls from Medicare or another governmental agency or another governmental agency inquiring about the relationship the inquiring about the relationship the physicians have with the DME company, physicians have with the DME company, what kinds of equipment were ordered what kinds of equipment were ordered and the names of the patients. and the names of the patients.

Introduction

• Or perhaps patients were interviewed in Or perhaps patients were interviewed in person by FBI agents. person by FBI agents.

• In any case, the DME company fears a In any case, the DME company fears a larger investigation is under way and larger investigation is under way and wishes to minimize the shock and fallout wishes to minimize the shock and fallout of further investigative actions.of further investigative actions.

Preparatory Steps

• There are a number of steps the DME There are a number of steps the DME company can take to prepare itself for a company can take to prepare itself for a possible government investigation.possible government investigation.

Preparatory Steps

• Corporate Compliance ProgramCorporate Compliance Program

• Regular Computer System BackupsRegular Computer System Backups– The company should regularly back up The company should regularly back up

its computer system and keep the its computer system and keep the backup files in a secure offsite backup files in a secure offsite location.location.

Preparatory Steps

• Comprehensive Document InventoryComprehensive Document Inventory– The company should maintain a The company should maintain a

detailed inventory of documents and detailed inventory of documents and their locations on the premises, e.g., their locations on the premises, e.g., a list of patient files, and which office a list of patient files, and which office and/or file cabinets they are kept in. and/or file cabinets they are kept in.

• Appoint a Company SpokespersonAppoint a Company Spokesperson

Preparatory Steps

• Employee TrainingEmployee Training– It is important to remember that the company It is important to remember that the company

should should notnot instruct its employees to refuse to instruct its employees to refuse to speak with investigators, because this could speak with investigators, because this could be construed as obstruction of justice. be construed as obstruction of justice.

– Rather, the company should instruct Rather, the company should instruct employees that it is employees that it is their choicetheir choice whether or whether or not to answer the investigator’s questions, not to answer the investigator’s questions, and that they have the right not to do so. and that they have the right not to do so.

– It is also their right to request that an attorney It is also their right to request that an attorney be present during questioning.be present during questioning.

Preparatory Steps

• RehearsalRehearsal– Too frequently, investigators take advantage of Too frequently, investigators take advantage of

situations where unsuspecting, frightened situations where unsuspecting, frightened employees act impulsively to release information employees act impulsively to release information that may be outside the boundaries of the that may be outside the boundaries of the investigation. investigation.

– It is easy, after the fact, for government agents to It is easy, after the fact, for government agents to claim that the employees released the information claim that the employees released the information voluntarily. voluntarily.

– A “fire drill” approach to rehearsing such a scenario A “fire drill” approach to rehearsing such a scenario is an effective way to prepare employees for the is an effective way to prepare employees for the real thing.real thing.

Preparatory Steps

• Retain a Health Care AttorneyRetain a Health Care Attorney

THE ENDA production of:

Brown & Fortunato, P.C.905 S. Fillmore, Suite 400

Amarillo, TX 79101806-345-6300

www.bf-law.com

Jeffrey S. Baird, [email protected]

806-345-6320

. I MPLEMENTING A S UCCESSFUL C OMPLIANCE P ROGRAM Presented by Jeffrey S. Baird, Esq. © 2015 Brown...

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Transcript of . I MPLEMENTING A S UCCESSFUL C OMPLIANCE P ROGRAM Presented by Jeffrey S. Baird, Esq. © 2015 Brown...