home health aggencies: regulatory and enforcement trends

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Presenting a live 90minute webinar with interactive Q&A Home Health Ag encies: Regulatory and Enforcement Trends Identifying Compliance Pitfalls and Minimizing Risk of Fraud and Abuse Investigations T d ’ f l f 1pm Eastern | 12pm Central | 11am Mountain | 10am Pacific TUESDAY, NOVEMBER 6, 2012 T odays faculty features: Laura F. Laemmle-Weidenfeld, Partner, Patton Boggs, Washington, D.C. Robert W. Markette, Jr., Of Counsel, Benesch Friedlander Coplan & Aronoff, Indianapolis The audio portion of the conference may be accessed via the telephone or by using your computer's speakers. Please refer to the instructions emailed to registrants for additional information. If you have any questions, please contact Customer Service at 1-800-926-7926 ext. 10.

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Page 1: Home Health Aggencies: Regulatory and Enforcement Trends

Presenting a live 90‐minute webinar with interactive Q&A

Home Health Agencies: gRegulatory and Enforcement TrendsIdentifying Compliance Pitfalls and Minimizing Risk of Fraud and Abuse Investigations

T d ’ f l f

1pm Eastern | 12pm Central | 11am Mountain | 10am Pacific

TUESDAY, NOVEMBER 6, 2012

Today’s faculty features:

Laura F. Laemmle-Weidenfeld, Partner, Patton Boggs, Washington, D.C.

Robert W. Markette, Jr., Of Counsel, Benesch Friedlander Coplan & Aronoff, Indianapolis

The audio portion of the conference may be accessed via the telephone or by using your computer's speakers. Please refer to the instructions emailed to registrants for additional information. If you have any questions, please contact Customer Service at 1-800-926-7926 ext. 10.

Page 2: Home Health Aggencies: Regulatory and Enforcement Trends

Tips for Optimal Quality

S d Q litSound QualityIf you are listening via your computer speakers, please note that the quality of your sound will vary depending on the speed and quality of your internet connection.

If the sound quality is not satisfactory and you are listening via your computer speakers, you may listen via the phone: dial 1-866-370-2805 and enter your PIN when prompted Otherwise please send us a chat or e mail when prompted. Otherwise, please send us a chat or e-mail [email protected] immediately so we can address the problem.

If you dialed in and have any difficulties during the call, press *0 for assistance.

Viewing QualityTo maximize your screen, press the F11 key on your keyboard. To exit full screen, press the F11 key againpress the F11 key again.

Page 3: Home Health Aggencies: Regulatory and Enforcement Trends

Continuing Education Credits FOR LIVE EVENT ONLY

For CLE purposes, please let us know how many people are listening at your location by completing each of the following steps:

• In the chat box, type (1) your company name and (2) the number of attendees at your locationattendees at your location

• Click the word balloon button to send

Page 4: Home Health Aggencies: Regulatory and Enforcement Trends

H H lth A i R l t dH H lth A i R l t dHome Health Agencies: Regulatory and Home Health Agencies: Regulatory and Enforcement TrendsEnforcement Trends

November 6, 2012November 6, 2012i fLaura Laemmle-Weidenfeld

Partner, Patton Boggs [email protected]

(202) 457-6542

WASHINGTON DC | NORTHERN VIRGINIA | NEW JERSEY | NEW YORK | DALLAS | DENVER | ANCHORAGE | DOHA | ABU DHABI

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Billing/Coding/Documentation Enforcement

• Significant documentation requirements for ffHHA combined with difficulty overseeing

compliance => perfect compliance storm

• Enforcement focus

• Particular areas of risk

• How to minimize risks

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Billing/Coding/Documentation Enforcement

• Significant enforcement focus– Criminal

Ci il (F l Cl i A t)– Civil (False Claims Act)– Administrative (OIG)

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Criminal Enforcement FocusCriminal Enforcement Focus

• Applicable laws:Applicable laws:– Wire fraud– Mail fraud– Health care fraudHealth care fraud– Conspiracy– Other

• Increasing activity• Increasing activity– DOJ-HHS Health Care Fraud Prevention and Enforcement

Action Team (HEAT) created in May 2009• Operates nationwide• Operates nationwide• Medicare Fraud Strike Force

– Focus on both corporate entities and individuals

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Recent Enforcement Actions

• Federal jury in Detroit convicted physician, HHA owner and patient recruiter for participating in $14 5 million Medicare fraud scheme (October 2012)participating in $14.5 million Medicare fraud scheme (October 2012)

– Patient recruiters allegedly paid beneficiaries to sign blank documents for PT services not provided and/or medically unnecessary

– HHA allegedly paid physicians to sign referrals and other therapy documents necessary to bill MedicarePTs and PTAs would allegedly create fake medical records to make it appear services– PTs and PTAs would allegedly create fake medical records to make it appear services actually were rendered

• October 2012 take-down by Strike Force – 7 cities – charges against 91 individuals– Indictments charged more than $230 million in Medicare home health fraud

• Owner of Miami HHA sentenced to 120 months in prison for $42M health care fraud scheme involving paying patient recruiters and physicians for false plans offraud scheme involving paying patient recruiters and physicians for false plans of care and medical certification and falsifying patient files (Oct. 2012)

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Civil False Claims Act

• Civil False Claims Act (FCA), 31 U.S.C. §3729 et seq.

• Revised in 2009 (Fraud and Enforcement Recovery Act), 2010 (Patient Protection and Affordable Care Act)C t i ll fil d b i t hi tl bl• Cases typically filed by private whistleblowers (qui tam provisions) beforeD t t f J ti h ibilit f• Department of Justice has responsibility for investigating, enforcing (Civil Frauds, USAOs)

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Conduct Prohibited Under FCA

• Submitting a claim for payment OR causing claim to be submitted for payment, by Government funds. 31 U.S.C. § 3729(a)(1)(A).p y , y § ( )( )( )

• Making or using, or causing to be made or used, false records or statements material to a false claim. 31 U.S.C. §3729(a)(1)(B).

• Making or using, or causing to be made or used, false records or statements material to an obligation to pay money or property to the Government, or knowingly concealing or improperly avoiding or decreasing an obligation to pay money to the Government 31or decreasing an obligation to pay money to the Government. 31 U.S.C. §3729(a)(1)(G).

• Conspiring to commit a violation of the FCA. 31 U.S.C. §3729( )(1)(C)§3729(a)(1)(C).

• All require “knowledge” and link to Government funding.

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Key Provisions• Knowledge:

– Defined by the statute asA t l k l d th t th l i t t t f l OR• Actual knowledge that the claim or statement was false, OR

• Deliberate ignorance of truth or falsity of the claim or statement, OR

• Reckless disregard of the truth or falsity of the claim or t t tstatement

– Proof of specific intent to defraud is NOT required

• Materiality: having a tendency to influence or beMateriality: having a tendency to influence or be capable of influencing payment or receipt of money or property

• Obligation: established duty, including that arising out of retention of any overpayment

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Damages and Penalties under the FCA

The FCA imposes:

• Treble the “amount of damages which the t t i b f th t”government sustains because of the act”

giving rise to liability.

• A civil penalty of $5,500 to $11,000 for each false claimfalse claim.

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HHS-OIG’s Exclusion Authority

• Exclusion: Medicare Medicaid and other Federal• Exclusion: Medicare, Medicaid and other Federal health programs won’t reimburse services provided, ordered or prescribed by individual or entity

• HHS-OIG has exclusive authority

• Issue arises in FCA cases and criminal cases as well• Issue arises in FCA cases and criminal cases, as well as administrative exclusion matters

• Mandatory and permissive 42 U S C §1320a-7Mandatory and permissive, 42 U.S.C. §1320a 7– Criminal convictions for health care fraud offenses =>

mandatory exclusion– Submission of false claims => permissive exclusion

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Home Health Services and OIG Work Plan for 2013OIG Work Plan for 2013

2013 OIG W k Pl l d O b 13 2012• 2013 OIG Work Plan released October 13, 2012

• Home Health Face-to-Face RequirementHome Health Face to Face Requirement

• Employment of Home Health Aides with Criminal Convictions

• Missing or Incorrect Patient Outcome andMissing or Incorrect Patient Outcome and Assessment Data

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Home Health Services and OIG Work Plan for 2013OIG Work Plan for 2013

• Medicare Administrative Contractors’ Oversight of ClaimsOversight of Claims

• Home Health Prospective Payment SystemHome Health Prospective Payment System Requirements

• Duplicate Payments by Medicare and Medicaid

• Screening of Health Care Workers

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Home Health Services and OIG Work Plan for 2013OIG Work Plan for 2013

• Provider Compliance and Beneficiary Eligibility

• Homebound Requirements

• Personal Care Services – Compliance with Payment RequirementsPayment Requirements

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HHS-OIG Studies/Reports

• Inappropriate and Questionable Billing by Medicare Home Health Agencies (OEI-04-11 00240 A t 2012)11-00240 August 2012)

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High-Risk Billing/Coding/Documentation IssuesIssues

• Issues at administrative level involving clinical and/or personnel issues

• Issues in field at caregiver level or supervisor levellevel

• Issues in billing office• Issues in billing office

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Clinical and Personnel-Related Administrative IssuesAdministrative Issues

• OASIS dataPhysician signatures/dates on plans of care 485• Physician signatures/dates on plans of care, 485 forms

• Prior authorization signatures• Background checks• Qualifications of caregiver • Exclusion checks• Exclusion checks

– Required by CIAs– If employee is excluded but HHA bills anyway, repayment is

required regardless of knowledgerequired regardless of knowledge• Documentation of homebound status• (Documentation of improvement standard)

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Caregiver Documentation Issues

• Inaccurately recording dates and times workedP ddi ti– Padding times

– Dates patient was in hospital, SNF, or deceased

• Pre-filling notesg• Inaccurately recording care given, vitals taken• Forging patients/families’ signatures• Homebound requirement (where applicable)• Billing time concurrent with another HHA

P t ti l f ll i ith ti t d/ f ili• Potential for collusion with patients and/or families

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Supervisory Issues

• Inaccurate documentation regarding date of supervisory visit

I t d t ti di h th• Inaccurate documentation regarding whether supervisory visit occurred

• Accurately documenting training and qualifications of individual caregiversqualifications of individual caregivers, assigning appropriately

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Billing Issues

• Billings all impacted by issues identified on prior slidesprior slides

• Failure to verify timesheet documentationFailure to verify timesheet documentation prior to billing

• Billing for higher level of service than provided

• Dual eligibles

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Mitigating Risks of Documentation/Coding/Billing IssuesDocumentation/Coding/Billing Issues

• Recognize risks are real despite good intentions of managementmanagement

• Create culture that values compliance, from CEO p ,down to lowest-skill caregiver

Task e er one in organi ation ith responsibilit for• Task everyone in organization with responsibility for identifying and stopping errors and fraud

• Create and maintain an effective compliance program

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Elements of an Effective Compliance ProgramProgram

• Written standards of conductD i d li ffi d l d i• Designated compliance officer and related governing bodies

• Regular effective education and training programsRegular, effective education and training programs for all employees

• Process to receive complaints, maintain anonymity of complainants, and protect them from retaliation

• Disciplinary system• Auditing• Auditing• Investigation and remediation

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How Not To Market: How Not To Market: Common Ways to Market

Yourself Into PrisonYourself Into Prison

Robert W. Markette, Jr. CHCOf CounselBenesch, Friedlander, Coplan & Aronoff LLPOne American Square Suite 2300One American Square, Suite 2300Indianapolis, IN 46282E-mail: [email protected]

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MY BENESCH MY TEAM

NOTE:

The materials and opinions presented by the speaker p p y pat this session represent the speaker’s views, are for educational and informational purposes only, are not intended to be legal advice and should not be used for legal guidance or to resolve specific legal problems. The speaker expressly reserves the right to advocate The speaker expressly reserves the right to advocate other positions on behalf of clients. In all cases, legal advice applicable to your organization’s own specific advice applicable to your organization s own specific circumstances should be sought.

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Marketing and the Medicare/Medicaid Provider:

Here comes the law!

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Many marketing practices that are considered Many marketing practices that are considered good business in other industries are considered illegal for Medicare/Medicaid Providers (including illegal for Medicare/Medicaid Providers (including Waiver).

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This is due to federal fraud and abuse lawsThis is due to federal fraud and abuse laws.

No remedy for fraud and abuse problems will be as No remedy for fraud and abuse problems will be as good as avoiding them in the first place.

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Basic Federal Fraud and Abuse Laws

Brief overview of the following laws:

The Anti Kickback Statute 42 U S C § 1320a 7b(b);The Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b);

Physician Self-Referral Law (Stark), 42 U.S.C. § 1395nn;

The Civil Monetary Penalties Statute, 42 U.S.C. § 1320a-7a; and,

The False Claims Act 31 U.S.C. §§ 3729, et. seq.

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Outside “marketing” companies

There are many options to contract with outside PR i f k tiPR companies for marketing.

OIG h t dl t t d h t OIG has repeatedly stated such arrangements should NOT involve commissions.

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Outside “marketing” companies

Recently, providers are being approached by “marketers” who are not really marketers.

They are individuals with “access” to a pool of referrals.

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Outside “marketing” companies

This may be through relationships or job. Marketer t b th ’ k ti t ff proposes to become the agency’s marketing staff.

R t f f l U ll fl t $250 Requests a fee per referral. Usually a flat $250 -$500. May request a “subscription fee” with bbonuses.

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Outside “marketing” companies

This type of arrangement is extremely risky. It is one to be avoided.

Yes, someone else may pay the fee, but you are seriously at risk for going to jail if you do.

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Inappropriate Marketing: Prizes, Gifts, and Other “Perks”,

Many non-healthcare businesses provide gifts to customers who refer clients to the business.

Since the purpose of giving a gift or having a prize giveaway is to generate goodwill with referral sources and/or patients, it meets the one purpose test.

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Prizes, Gifts and other “Perks”

Other Examples:pMealsH HHappy HourSpa Day

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Prizes, Gifts and other “Perks”

Recent Face to Face example:p

Physician requesting agency pay “administrative y q g g y p yfee” before physician will prepare face to face documentation.

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Prizes, Gifts and other “Perks”

Providing items of value to patients as an Providing items of value to patients as an inducement to select the provider for reimbursable services violates the CMP reimbursable services violates the CMP statute.

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Prizes, Gifts and other “Perks”

Examples:pFree ServicesF E i tFree EquipmentFree Chair

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Prizes, Gifts and other “Perks”

Examples:pMovie TicketsT t ti OIG i i l ttTransportation – OIG opinion lettersOther Gifts

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Prizes, Gifts and other “Perks”

OIG will not prosecute violations that involve “nominal value ”“nominal value.”

Nominal Value means less than $10 per person p pand totaling no more than $50 per year to each person.p

Think small gifts.

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Free Services

OIG has issued a number of advisory opinions di th i i f f it i regarding the provision of free items or services

to beneficiaries and in almost every instance, the f it i t b fi i i f d free items or services to beneficiaries were found to be a violation of the fraud and abuse laws.

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Free Services

Two Examples:

Advisory Opinion on Free Home Safety A tAssessments

Ad i O i i f F H OAdvisory Opinion of Free Home Oxygen

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Free Services

In both of these cases, OIG looked at the “perceived value” of the services As a result the “perceived value” of the services. As a result, the minimal value exception did not apply.

This means if you provide free items or services, even if it does not cost you a lot it is probably not even if it does not cost you a lot, it is probably not minimal value.

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Special Cases

Health FairsHealth fairs are one of the most common forms of home health marketing. Many agencies participate in health fairs as a way to generate p p y gnew business.Recent Opinion on Free Blood Pressure Recent Opinion on Free Blood Pressure Screening.

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Free Staffing to Referral Source

This situation can come up in a number of ways. A home health agency might send a nurse to a g y greferring physician’s office to help them complete their paperwork to obtain reimbursement. A p phospice may provide staff to a nursing facility to perform duties that would otherwise be performed p pby nursing facility staff.

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Free Staffing to Referral Source

If you provide staff for free or below fair market value to a referral source to perform the duties value to a referral source to perform the duties normally performed by the referral source’s staff, you are providing them with something of value you are providing them with something of value – staff.

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Free Staffing to Referral Source

If the free staffing is being provided to increase g g preferrals, it is a violation.

Hard to explain why staff being provided for free.

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Free Staffing to Referral Source

A provider may provide staffing to a referral if th t i t t d t t source if the arrangement is structured to meet

what is known as the personal services safe h b t th A ti Ki kb k lharbor to the Anti-Kickback law.

Thi f h b i t th thi This safe harbor requires, amongst other things, fair market value.

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Free Staffing to Referral Source

Home health agencies have provided referring physicians with smart phones and other physicians with smart phones, and other communications devices in order to “ensure care coordination ”coordination.This is also a violation. While you may argue it is provided for a legitimate reason it can be used by provided for a legitimate reason, it can be used by the physician for any number of other purposes.

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Medical Directors

If the physician who acts as your medical director is a source of referrals, the relationship can violate not only the Anti-Kickback statute, but also the Stark law.

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Medical Directors

The AKS and the Stark Law have a safe harbor/exception into which a medical director relationship can fit.p

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Medical Directors

Medical director relationships must be provided t t t t th t t ll f th pursuant to a contract that meets all of the

requirements of the Exception/Safe Harbors.

Both the Safe Harbor and the Exception require th ti b f i k t lthe compensation be fair market value.

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Medical Directors

Some providers “hire” medical directors simply as a way to secure referrals Risks:way to secure referrals. Risks:

Multiple medical directors

Paying more than FMV

Paying for services not rendered

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Medical Directors

Having the contract in place is not enough. Relationship must operate in compliance with contract. You must be prepared to prove compliance.Document. Document. Document.Q: Can you prove what physician is doing, other than referring patients, to justify payments?referring patients, to justify payments?

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Fraud and Abuse In LTC Relationships

OIG has issued a number of bulletins outlining its b t th i k i h h lth d concerns about the risks in home health and

hospice relationships with facilities. Concerns f i k i ill ff i d t t focus on risk agencies will offer inducements to “gain access.”

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Fraud and Abuse In LTC Relationships

Example: A nursing home requests a hospice p g q pprovide items or services to a hospice beneficiary that is covered by the nursing home y y gper diem.

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Fraud and Abuse In LTC Relationships

Because the services are covered by the nursing y ghome per diem, if the hospice provides them instead, the nursing home reduces its costs. This gincreases the nursing homes profits and is remuneration to the home.

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Fraud and Abuse In LTC Relationships

A facility may request the agency provide staff generally or staff the agency’s patients at a level generally or staff the agency’s patients at a level that is not indicated. Again, if the hospice staff is providing care the facility would otherwise provide providing care the facility would otherwise provide as part of the nursing home per diem, the nursing home is receiving remunerationhome is receiving remuneration.

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Fraud and Abuse In LTC Relationships

Other examples:Facility requests hospice to provide Facility requests hospice to provide

“continuous care” to all hospice patients in facility.F ilit t id l t d th Facility requests provider use related therapy

company and then “suggests” excessive services to ti tpatients.

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Fraud and Abuse In LTC Relationships

Other examples:Facility requests agency provide supplies that Facility requests agency provide supplies that

are covered by per diem or excessive amounts of supplies for hospice patientssupplies for hospice patients.

Facility requests agency take on “marginal cases.”

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Fraud and Abuse In LTC Relationships

Last summer, OIG issue report outlining concerns b t t i “l t ” h i ti t b i about certain “long term” hospice patients being

cared for in facilities.

RISK: Taking on marginal patients to please f i f ilitreferring facility.

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Fraud and Abuse In LTC Relationships

These types of issues can come up in relationships These types of issues can come up in relationships with other facilities as well. Assisted living facilities for examplefor example.

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Fraud and Abuse In LTC Relationships

Assisted Living Facilities may “offer” an agency Assisted Living Facilities may offer an agency office space.

May request a provider perform certain services.

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Fraud and Abuse In LTC Relationships

Example: ALF requests agency keep an RN on-Example: ALF requests agency keep an RN onsite at all times, because agency’s patients may “need to talk to someone.” ALF then advertises need to talk to someone. ALF then advertises “RN available 24/7.”

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Fraud and Abuse In LTC Relationships

May “request” agency use facility or related therapy t ff t h h lth ti t i th staff to serve home health agency patients in the

facility.

They may also “advocate” for more services on POCPOC.

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Avoiding problems

In your practice as a Medicare or Medicaid provider you must be sensitive to the fact that provider, you must be sensitive to the fact that many arrangements that are acceptable business practices in other fields are fraud and abuse practices in other fields are fraud and abuse violations.

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Avoiding problems

You also must be sensitive to the fact that both f d l d t t t b i federal and state governments are becoming more aggressive in their attempt to eliminate

i d tili ti d t t tperceived over-utilization and to cut costs.

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Avoiding problems

1. Train, train, and retrain your marketing personnel The pressure to go compete in home personnel. The pressure to go compete in home health and to “successfully” market, can lead marketing personnel to try to keep up with marketing personnel to try to keep up with competitors. This can lead you into violations of federal lawsfederal laws.

Training is key to compliance.

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Avoiding problems

For marketing compliance, your marketers, and certain clinical staff, are most likely to see or to be approached about suspect arrangements.

They need to know where the lines are at to avoid crossing them.

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Avoiding problems

2. Make sure you have compliance oversightof new marketing categories and effortsof new marketing categories and efforts.

3 Ensure arrangements meet applicable safe 3. Ensure arrangements meet applicable safe harbors on paper and in practice. Requires auditing of relationshipsauditing of relationships.

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Avoiding problemsg

4 When in doubt about a potential 4. When in doubt about a potential marketing practice or joint venture, seek the advice of counselseek the advice of counsel.

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Avoiding problems

If you rely upon a safe harbor that relates to values per individual or totals in a year – TRACK AMOUNTS GIVEN.

This applies to “minimal value” and non-monetary compensation.

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OVERPAYMENTSOVERPAYMENTS

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OverpaymentsOverpayments

• Potential liability under the civil False Claims Act (FCA) for failure to return overpayments

• Obligation to return “overpayments” created under 2009 Fraud Enforcement andunder 2009 Fraud Enforcement and Recovery Act (FERA) and 2010 Patient Protection and Affordable Care Act (ACA)o ec o a d o dab e Ca e c ( C )

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FCA and Overpayments

• Relevant FCA provision for “reverse false claims” includes knowingly concealing or improperly avoidingor decreasing an obligation to pay money to the Government §3729(a)(1)(G) (emphasis added)Government, §3729(a)(1)(G) (emphasis added)

• Added by FERA in 2009

• “Obligation” in the FCA redefined under FERA to include “retention of any overpayment”include retention of any overpayment

• 60-day repayment requirement imposed by ACA

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Overpayments and 60-Day Rule• Statutory 60-day rule (Social Security Act § 6402)

– Requires specifically that all providers report and return overpayments within the later of sixty (60) days of identifyingoverpayments within the later of sixty (60) days of identifying the overpayment or the date the corresponding cost report is due, “if applicable.” 42 U.S.C. § 1320a-7k(d).

– Defines “overpayment” to mean “any funds that a person receives or retains under [a FHCP] to which the person afterreceives or retains under [a FHCP] to which the person, after applicable reconciliation, is not entitled under such title.” 42 U.S.C. § 1320a-7k(d)(2).

– Defines an overpayment retained after such deadline as an “ bli i ” d h FCA 42 U S C § 1320 7k(d)(3)“obligation” under the FCA. 42 U.S.C. § 1320a-7k(d)(3).

– Defines terms “knowing” and “knowingly” as having the same meaning given under the FCA, but the statute otherwise does not employ those terms, leaving definitions p y , gfor terms that otherwise are not used. 42 U.S.C. § 1320a-7k(4)(A).

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Overpayments and 60-day Rule (continued)

• Proposed 60-day regulations (issued by CMS on February 16 2012)February 16, 2012)– Proposed rule applies only to Medicare Part A and Part B

providers and suppliers– Proposes to adopt the statutory definition of “overpayment” p p y p y

which applies broadly to almost any time a provider/supplier receives more reimbursement that it should have

– Proposes that a provider/supplier has “identified” an overpayment once it has “actual knowledge of the existenceoverpayment once it has actual knowledge of the existence of the overpayment or acts in reckless disregard or deliberate ignorance of the overpayment”

– CMS references self-audits and compliance checks as being generally required to avoid deliberate ignorance andgenerally required to avoid deliberate ignorance and reckless disregard

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Overpayments and 60-day Rule (continued)

• Proposed 60-day regulations (continued)– Proposed timeline for reporting and returning overpayments:– Proposed timeline for reporting and returning overpayments:

• If an overpayment is claims-related, the provider must report and return the overpayment within sixty (60) days of identifying the overpayment. If the overpayment is the type that ordinarily would be reconciled through the cost reports, then the provider can report and return the o erpa ment either ithin si t (60) da s after identif ing theoverpayment either within sixty (60) days after identifying the overpayment or on the date that the cost report is due.

• Receipt of information by a provider or supplier regarding a potential overpayment “creates an obligation to make a reasonable inquiry” to determine whether an overpayment has, in fact, occurred. Then, “[i]f ythe reasonable inquiry reveals an overpayment, the provider then has 60 days to report and return the overpayment.”

• If the provider or supplier fails to make a reasonable inquiry, or fails to conduct such an inquiry “with reasonable speed,” then the provider or supplier could be viewed as having knowingly retained thesupplier could be viewed as having knowingly retained the overpayment on the grounds that it had “acted in reckless disregard or deliberate ignorance” of an overpayment.

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Overpayments and 60-day Rule (continued)

• Proposed 60-day regulations (continued)– Fails to specify whether quantifying the overpayment is

inherent in the definition of “identifying” the overpayment.

– Proposed 10-year look-back period (through extension of time to re-open claims)

• Effectively adopting FCA statute of limitations• Could create significant issues for providers

– Self-reporting under CMS’s Medicare Self-Referral Disclosure Protocol (SRDP) and HHS-OIG’s Self-Disclosure Protocol (SDP) tolls repayment obligation

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Overpayments and Exclusion

Th Ci il M t P lti (CMP) t t t• The Civil Monetary Penalties (CMP) statute was amended by PPACA to impose CMPs for knowing about an overpayment and failing toknowing about an overpayment and failing to report or return it. 42 U.S.C. § 1320a-7a(a)(10).

• Permissive exclusion provisions permit HHS-OIG to exclude any provider/supplier thatOIG to exclude any provider/supplier that violates the CMP statute. 42 U.S.C. § 1320a-7(b)(7).

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Open Questions Regarding Overpayments

When is an overpayment “identified”?• When is an overpayment “identified”?• At what point does the PPACA 60-day rule

begin to run and what triggers it?g gg• What level of legal and regulatory certainty is

required for there to be an “overpayment”?How far back must a provider look for• How far back must a provider look for overpayments?

• What level of review for overpayments is p ynecessary for a provider to have made a reasonable inquiry?

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PREFERRED PROVIDER AGREEMENTS AND OTHER AGREEMENTS AND OTHER

ARRANGEMENTS

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Health care reform is leading to more Health care reform is leading to more collaboration across the continuum of care. ACO’s bundling and similar pilot projects as ACO s, bundling and similar pilot projects, as well as reimbursement pressures are resulting in providers looking to partnerin providers looking to partner.

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Preferred Provider Agreements

Preferred provider agreements have been an accepted arrangement in the hospital and physician accepted arrangement in the hospital and physician realm for many years.

These arrangements are coming to long term care as agencies and facilities look to “partner” with as agencies and facilities look to partner with each.

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Preferred Provider Agreements

In a preferred provider agreement, one party or both parties designate the other one as preferredboth parties designate the other one as preferred.

For a home health or hospice agency, this will lead to an increase in referrals.

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Preferred Provider Agreements

These agreements generally focus on quality, communications, and speed of admissions.

IMPORTANT: They do not usually call for any value to be exchanged.

IMPORTANT Th l i d t t IMPORTANT: They also recognize and protect patient choice.

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Preferred Provider Agreements

Problems arise when there are related agreements or “understandings”agreements or understandings .

Example: Preferred provider rents space from Example: Preferred provider rents space from referring hospital. The rental agreement can become the remuneration that led to the become the remuneration that led to the preferred provider agreement.

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Preferred Provider Agreements

Problems also arise when value is involved.

Example: Home health agency agrees, as preferred provider to provide CEUs to hospital preferred provider, to provide CEUs to hospital staff.

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Joint Ventures

The term joint venture can describe many business relationships They can be a great way for two or relationships. They can be a great way for two or more entities to pool resources in order to start a new business new business.

However OIG suspects that they are an effort to However, OIG suspects that they are an effort to disguise remuneration being paid for referrals.

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Joint Ventures

Although providers have long shied away from joint ventures as the marketplace becomes more competitive, they are starting to return.

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Joint Ventures

OIG has repeatedly stated that it will carefully scrutinize joint ventures involving investors who are scrutinize joint ventures involving investors who are in a position to refer federal health care program business to the venture or to co investorsbusiness to the venture or to co-investors.

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Joint Ventures

Two types of Joint VenturesOwnership Joint VenturesContractual Joint VenturesContractual Joint Ventures

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Joint Ventures

There is a safe harbor that might be used to structure ownership joint ventures It is called the structure ownership joint ventures. It is called the small investment interest safe harbor. As we will see most JVs do not fit into it It has eight see, most JVs do not fit into it. It has eight elements.

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Small Investment Safe Harbor

1. No more than forty percent of the entity may be owned by individuals or entities who have the power to make or influence referrals to the entity, furnish items or services to the entity, or otherwise generate business for the entity.

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Small Investment Safe Harbor

2. Investment interests must be offered on the 2. Investment interests must be offered on the same terms to interested investors as they are offered to other investors.offered to other investors.

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Small Investment Safe Harbor

The terms on which an investment interest is offered to an interest investor must not be related to the previous or expected volume of referrals, p pitems or services furnished, or the amount of business otherwise generated from that investor gto the entity.

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Small Investment Safe Harbor

3. There is no requirement that a passive q pinvestor, makes referrals to, be in a position to make or influence referrals to, furnish items or services to, otherwise generate business for the entity as a condition for remaining as an investor.y g

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Small Investment Safe Harbor

4 The entity or any investor must not market or 4. The entity or any investor must not market or furnish the entity’s items or services to passive investors differently than to non-investorsinvestors differently than to non-investors.

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Small Investment Safe Harbor

5. No more than forty percent of the entity’s gross revenue related to the furnished of health care items and services in the previous fiscal year or previous 12 month period may come from referrals or business otherwise generated from the investors.

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Small Investment Safe Harbor

6 The entity or any investor must not loan 6. The entity or any investor must not loan funds to or guarantee a loan for a potential referring investor if that loan is used to purchase referring investor if that loan is used to purchase an interest in the company.

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Small Investment Safe Harbor

7. The amount of payment to an investor in 7. The amount of payment to an investor in return for the investment interest must be directly proportional to the amount of the capital proportional to the amount of the capital investment of that investor.

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Small Investment Safe Harbor

Most JVs will not have 60% disinterested Most JVs will not have 60% disinterested investors. However, it can be a defense to be close, even if you do not fit into it.close, even if you do not fit into it.

Important to structure ownership ventures with Important to structure ownership ventures with this in mind.

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Contractual Joint Venture

The other form of joint venture is known as a contractual joint venture. In this situation, the provider looking to branch out into a new area contracts with another provider to “manage” the new entities.

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Contractual Joint Venture

As with ownership ventures, OIG is concerned that the contract may simply be a tool to disguise payments for referrals.

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Contractual Joint Venture

Problematic contractual joint ventures involve the owner not investing in the new venture and basically contracting with the “manager” to provide substantially all of the aspects of the new business.

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Contractual Joint Venture

OIG has issued bulletins that list “red flags.” Important to structure relationship to avoid those flags.

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Joint Venture Operational Issues

Important. Forming the joint venture correctly in the first place is only the first step.

The venture must operate in compliance with the agreements, corporate structure, etc.

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Joint Venture Operational Issues

Any JV or preferred provider agreement should be regularly monitored to ensure compliant operations. Failing to do so can lead to a compliant venture becoming a source of significant liability.

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Joint Venture Operational Issues

Problems can arise in how profits are distributed, how management fees are calculated and paid, how investors with other contractual relationships to JV are treated, etc.

Many aspects of a JV can become a vehicle for illegal referrals.

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Joint Venture

Whenever you are approached about a potential joint venture, you should not take any action without j , y yseeking the advice of counsel that is thoroughly familiar with fraud and abuse laws.

You may find your well intentioned business venture has become a source of immense liabilityhas become a source of immense liability.

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Avoiding problems

Preferred provider arrangements and joint venture agreements may seem like an excellent way to g y ydevelop new referrals.

If o do not both form and operate them correctl If you do not both form and operate them correctly, the liability you incur will far outstrip the profits you gaingain.

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