The Changing Perspective on Kickback Enforcement Greater Kansas - - PDF document

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The Changing Perspective on Kickback Enforcement Greater Kansas - - PDF document

12/17/2019 The Changing Perspective on Kickback Enforcement Greater Kansas City MGMA Stacy Harper, JD, MHSA, CPC sharper@spencerfane.com Spencer Fane LLP | spencerfane.com Disclaimer This presentation is for educational purposes. It is not


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The Changing Perspective on Kickback Enforcement

Greater Kansas City MGMA Stacy Harper, JD, MHSA, CPC sharper@spencerfane.com

Spencer Fane LLP | spencerfane.com

Disclaimer

This presentation is for educational

  • purposes. It is not legal advice and does not

create an attorney-client relationship or attorney-client privilege. The opinions provided are that of the speaker and do not represent formal positions of MGMA or Spencer Fane LLP.

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Overview

  • Stark and Anti-Kickback Fact Analysis
  • Forest Park Case
  • Travel Act
  • EKRA
  • Proposed Regulations
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Fact Scenario

  • Physician Owned Hospital
  • Physician-owned landlord
  • Physician-owned staffing/administrative

company

  • Physician-owned management company
  • Out-of-network all payers
  • Urban area

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Hospital Real Estate Company Staffing Company Management Company Referring Physicians Ownership Ownership Ownership Ownership Consulting Agreements Lease Staffing Agreement Management Agreement

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Stark Law

  • If a physician (or immediate family member)

has a financial relationship with an entity, then the physician may not make referral to the entity for the furnishing of designated health services for which payment is made by Medicare or Medicaid and the entity may not bill Medicare or Medicaid for any such referred services.

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Stark Law – Threshold Analysis

  • Physician (or immediate family member)
  • Financial Relationship
  • Referral
  • Designated Health Services
  • Medicare or Medicaid

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Stark Law - Physician

– Medical Doctor (MD) – Doctor of Osteopathy (DO) – Dentist (DDS) – Podiatrist (DPM) – Optometrist (OD) – Chiropractor (DC)

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Stark Law – Immediate Family

– husband or wife; – birth or adoptive parent, child, or sibling; – stepparent, stepchild, stepbrother, or stepsister; – father-in-law, mother-in-law, son-in-law, daughter- in-law, brother-in-law, or sister-in-law; – grandparent or grandchild; and – spouse of a grandparent or grandchild

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Stark Law - Financial Relationship

Compensation

Any remuneration between the physician and the entity

Investment

Stock, partnership shares, LLC memberships, loans, bonds, and

  • ther secured

financial instruments

Direct

Relationship is between the Physician (or the Physician’s Practice) and the Entity

Indirect

Relationship is through a chain of entities between the Physician and the Entity Spencer Fane LLP | spencerfane.com

Stark Law - Referral

  • Referral

– the request by a physician for, or ordering of a designated health service, – the establishment of a plan of care by a physician that includes the provision of such a designated health service, or – the certifying or recertifying of the need for, any designated health service – a request for a consultation with another physician and any test

  • r procedure ordered by or to be performed by (or under the

supervision of) that other physician, – but not including any designated health service personally performed or provided by the referring physician.

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Stark Law – Designated Health Services (DHS)

Clinical Laboratory Services Physical, occupational, and speech‐ language therapy Radiology and other imaging Radiation therapy Durable Medical Equipment Parenteral and enteral nutrients, equipment, and supplies Prosthetic, orthotics, and prosthetic devices Home health services Outpatient prescription drugs Inpatient and outpatient hospital services

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Stark Law – Medicare or Medicaid

  • Triggered by the involvement of a claim
  • Claim does not have to relate to the

financial relationship

  • Application is not as clear for Medicaid

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Stark Law - Exceptions

  • Publically traded Securities
  • Mutual Funds
  • Rural Providers
  • In-Office Ancillary
  • Physician Services
  • Academic Medical Centers
  • ASC Implants
  • Preventative Screening
  • Eyeglasses and Contacts
  • Rental Office Space
  • Rental Equipment
  • Employment
  • Personal Service Arrangements
  • Physician Recruitment
  • Isolated Transactions
  • Certain Arrangements with Hospitals
  • Payments by a Physician
  • Non-monetary compensation
  • Fair Market Value Compensation
  • Risk-sharing Relationships
  • Compliance Training
  • Indirect Compensation
  • Referral Services
  • OB Malpractice Subsidies
  • Professional Courtesy
  • Retention Payments
  • Community-wide Health Information
  • E-Prescribing and Electronic Health Records
  • Assistance for Non-physician Practitioner
  • Timeshare Arrangements

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Stark Law – Physician Owned Hospital

  • Hospital had physician ownership and a provider agreement on

December 31, 2010

  • No expansion of operating rooms, procedure rooms or beds after

March 23, 2010

  • Disclosure of ownership interest
  • Percentage of physician ownership fixed on March 23, 2010
  • Ownership not offered to physicians on more favorable terms
  • No loan for investment
  • Distributions based on ownership
  • Physicians not offered right to purchase other business interests
  • Physicians not offered opportunity to purchase or lease property
  • Patient safety requirements
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Stark Law – Indirect Compensation

  • The compensation received by the referring physician is fair market value for services and

items actually provided and not determined in any manner that takes into account the volume or value of referrals or other business generated by the referring physician for the entity furnishing DHS.

  • Compensation for the rental of office space or equipment may not be determined using a

formula based on—

– A percentage of the revenue raised, earned, billed, collected, or otherwise attributable to the services performed or business generated in the office space or to the services performed on or business generated through the use of the equipment; or – Per-unit of service rental charges, to the extent that such charges reflect services provided to patients referred by the lessor to the lessee.

  • The compensation arrangement is set out in writing, signed by the parties, and specifies

the services covered by the arrangement, except in the case of a bona fide employment relationship between an employer and an employee, in which case the arrangement need not be set out in writing, but must be for identifiable services and be commercially reasonable even if no referrals are made to the employer.

  • The compensation arrangement does not violate the anti-kickback statute (section

1128B(b) of the Act), or any Federal or State law or regulation governing billng or claims submission.

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Stark Law – Personal Services

  • Each arrangement is set out in writing, is signed by the parties, and specifies the services

covered by the arrangement.

  • The arrangement(s) covers all of the services to be furnished by the physician to the entity.
  • The aggregate services covered by the arrangement do not exceed those that are

reasonable and necessary for the legitimate business purposes of the arrangement(s).

  • The duration of each arrangement is at least 1 year.
  • The compensation to be paid over the term of each arrangement is set in advance, does not

exceed fair market value, and, except in the case of a physician incentive plan, is not determined in a manner that takes into account the volume or value of any referrals or other business generated between the parties.

  • The services to be furnished under each arrangement do not involve the counseling or

promotion of a business arrangement or other activity that violates any Federal or State law.

  • If the arrangement expires after a term of at least 1 year, a holdover arrangement

immediately following the expiration of the arrangement satisfies the requirements of this section if additional conditions are met.

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Hospital Real Estate Company Staffing Company Management Company Referring Physicians Ownership Ownership Ownership Ownership Consulting Agreements Lease Staffing Agreement Management Agreement

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Anti-Kickback Statute

  • Prohibits anyone from knowingly and willfully solicits or

receives any remuneration, directly or indirectly,

  • vertly or covertly, in cash or in kind in return for

– referring an individual to a person for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part by a Federal healthcare program – for purchasing, leasing, ordering, or arranging for or recommending purchasing, leasing, or ordering any good, facility, service, or item for which payment may be made in whole or in part under a Federal health care program

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Anti-Kickback Statute – Threshold Analysis

  • Anyone
  • Remuneration
  • Referral, Purchase, Recommend
  • Item or Service
  • Federal Healthcare Program

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Anti-Kickback Statute - Anyone

  • Not limited to certain providers
  • Anyone involved in healthcare
  • Can be the patient him/herself
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Anti-Kickback Statute - Remuneration

  • Anything of value
  • In cash or in kind
  • Can be discounts as well as payments

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Anti-Kickback Statute - Referral

  • Very broadly defined
  • Includes

– Referral – Purchase – Order – Lease – Arrange – Recommend

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Anti-Kickback Statute – Item or Service

  • Not limited to particular services
  • Includes DHS as well as other services
  • Based on potential coverage
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Anti-Kickback Statute – Federal Healthcare Programs

  • Medicare
  • Medicaid
  • Medicare Advantage
  • Tricare
  • Federal Employees
  • Mail Handlers
  • ETC.

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Anti-Kickback Statute – Safe Harbors

  • Investment Interests
  • Space Rental
  • Equipment Rental
  • Personal Services and Management
  • Sale of Practice
  • Referral Services
  • Warranties
  • Discounts
  • Employees
  • Group Purchasing Organizations
  • Waiver of co-payments
  • Increased coverage by health plans
  • Price reductions by health plans
  • Practitioner Recruitment
  • OB malpractice subsidies
  • Investments in group practices
  • Cooperative hospital service
  • rganizations
  • Ambulatory Surgery Centers
  • Managed care organizations
  • Ambulance replenishing
  • Health Centers
  • E-prescribing and EHRs
  • FQHCs and Medicare Advantage
  • Medicare Gap Coverage Discount
  • Local Transportation

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Anti-Kickback Statute – Knowingly and Willfully

The Statute is violated where one purpose of the remuneration is to encourage the referral.

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Anti-Kickback Statute - Ownership

  • No Safe Harbor
  • 1994 Fraud Alert on Joint Ventures

– The manner in which investors are selected and retained; – The nature of the business structure of the joint venture; and – The financing and profit distributions.

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Anti-Kickback Statute - Lease

  • The lease agreement is set out in writing and signed by the parties.
  • The lease covers all of the premises leased between the parties for the term of the lease and

specifies the premises/equipment covered by the lease.

  • If the lease is intended to provide the lessee with access to the premises/equipment for periodic

intervals of time, rather than on a full-time basis for the term of the lease, the lease specifies exactly the schedule of such intervals, their precise length, and the exact rent for such intervals.

  • The term of the lease is for not less than one year.
  • The aggregate rental charge is set in advance, is consistent with fair market value in arms-length

transactions and is not determined in a manner that takes into account the volume or value of any referrals or business otherwise generated between the parties for which payment may be made in whole or in part under Medicare, Medicaid or other Federal health care programs.

  • The aggregate space/equipment rented does not exceed that which is reasonably necessary to

accomplish the commercially reasonable business purpose of the rental. Note that for purposes of paragraph (b) of this section, the term fair market value means the value of the rental property for general commercial purposes, but shall not be adjusted to reflect the additional value that one party (either the prospective lessee or lessor) would attribute to the property as a result of its proximity or convenience to sources of referrals or business otherwise generated for which payment may be made in whole or in part under Medicare, Medicaid and all other Federal health care programs.

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Anti-Kickback Statute – Personal Services

  • The agency agreement is set out in writing and signed by the parties.
  • The agency agreement covers all of the services the agent provides to the principal for the term of

the agreement and specifies the services to be provided by the agent.

  • If the agency agreement is intended to provide for the services of the agent on a periodic,

sporadic or part-time basis, rather than on a full-time basis for the term of the agreement, the agreement specifies exactly the schedule of such intervals, their precise length, and the exact charge for such intervals.

  • The term of the agreement is for not less than one year.
  • The aggregate compensation paid to the agent over the term of the agreement is set in advance,

is consistent with fair market value in arms-length transactions and is not determined in a manner that takes into account the volume or value of any referrals or business otherwise generated between the parties for which payment may be made in whole or in part under Medicare, Medicaid

  • r other Federal health care programs.
  • The services performed under the agreement do not involve the counselling or promotion of a

business arrangement or other activity that violates any State or Federal law.

  • The aggregate services contracted for do not exceed those which are reasonably necessary to

accomplish the commercially reasonable business purpose of the services.

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Hospital Real Estate Company Staffing Company Management Company Referring Physicians Ownership Ownership Ownership Ownership Consulting Agreements Lease Staffing Agreement Management Agreement

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Forest Park Medical Center of Kansas City, LLC

  • Entity formed to build a Forest Park hospital in

Johnson County, Kansas

  • Over a dozen physician, plus several physician

practice investors

  • $4 Million invested
  • Development progress ceased in approximately

2015

  • Litigation filed in Kansas and Texas related to

diverting of funds to the Texas entities

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What Does the DOJ See

  • No participation with Medicare or Medicaid
  • Complex structure of physician ownership and

contracts

  • Luxury facilities
  • Patients driving across town for procedures
  • Out of network for all payers
  • Advertised waiver of patient co-payments
  • Over $200 Million in claims paid over approximately 4

years

  • Filed for bankruptcy
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Forest Park Case

  • 2016 Indictment of 21 individuals
  • Allegations Included:

– Anti-Kickback Statute related to Tricare and federal worker’s compensation – Anti-Kickback Statute related to Medicare and Medicaid (referral to other hospitals) – Travel Act – Texas Anti-Bribery Statute

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Forest Park – Alleged Conduct

  • Shell Entities
  • Consulting Agreements
  • Marketing Agreements
  • Waiver of Out-of-Network Co-Payments
  • Tracking of revenue generated

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Forest Park Case

  • 10 defendants pled guilty
  • 9 defendants continued to trial in 2019

– 7 found guilty – 1 acquitted – 1 mistrial (subsequent plea)

  • Pending Appeals
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Travel Act

  • Whoever travels in interstate commerce or uses

the mail or any facility in interstate or foreign commerce with intent to:

– distribute the proceeds of any unlawful activity; or – commit any crime of violence to further any unlawful activity; or – otherwise promote, manage, establish, carry on, or facilitate the promotion, management, establishment,

  • r carrying on, of any unlawful activity,

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Travel Act – Unlawful Activity

  • any business enterprise involving gambling, liquor on which

the Federal excise tax has not been paid, narcotics or controlled substances (as defined in section 102(6) of the Controlled Substances Act), or prostitution offenses in violation of the laws of the State in which they are committed

  • r of the United States,
  • extortion, bribery, or arson in violation of the laws of the State

in which committed or of the United States, or

  • any act which is indictable under subchapter II of chapter 53
  • f title 31, United States Code, or under section 1956 or 1957
  • f this title

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Texas Anti-Bribery Law

  • A person who is a fiduciary commits an offense if, without the

consent of his beneficiary, he intentionally or knowingly solicits, accepts, or agrees to accept any benefit from another person on agreement or understanding that the benefit will influence the conduct of the fiduciary in relation to the affairs of his beneficiary.

  • Fiduciary includes:

– an agent or employee; – a trustee, guardian, custodian, administrator, executor, conservator, receiver, or similar fiduciary; – a lawyer, physician, accountant, appraiser, or other professional advisor; or – an officer, director, partner, manager, or other participant in the direction

  • f the affairs of a corporation or association.
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Missouri Anti-Bribery Law

  • knowingly violating or agreeing to violate a duty of fidelity, which he or she is

subject to as: – An agent or employee of another; – A trustee, guardian or other fiduciary; – A lawyer, physician, accountant, appraiser or other professional adviser

  • r informant;

– An officer, director, partner, manager or other participant in the direction

  • f the affairs of an incorporated or unincorporated association; or

– An arbitrator or other purportedly disinterested adjudicator or referee;

  • As a person who holds himself or herself out to the public as being engaged

in the business of making disinterested selection, appraisal or criticism of commodities or services, solicits, accepts or agrees to accept any benefit to influence his or her selection, appraisal or criticism

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Kansas Anti-Bribery Law

  • knowingly violating or agreeing to violate a duty of fidelity or

trust by: – An agent or employee of another; – A person acting in a fiduciary capacity; – A lawyer, physician, accountant, appraiser or other professional adviser; – An officer, director, partner, manager or other participant in the affairs of a corporation, partnership or unincorporated association; or – An arbitrator or other purportedly disinterested adjudicator

  • r referee.

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EKRA (Eliminating Payments in Recovery Act)

  • It is unlawful to knowingly and willfully

solicit, receive, pay or offer remuneration, directly or indirectly, to induce a referral of an individual to a recovery home, clinical treatment facility, or laboratory.

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EKRA – Threshold Analysis

  • Remuneration
  • Individual
  • Recovery Home, Clinical Treatment

Facility or Laboratory

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EKRA – Exceptions and Intent

  • Exceptions (no regulations yet)

– Discounts – Employees – Principal to agent – Co-insurance waiver – Alternative payment models

  • Knowing and willful

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Proposed Regulations - Stark

  • Definition Changes

– Commercially reasonable – Designated Health Services – Fair Market Value – Isolated Financial Transaction – New value-based definitions

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Proposed Regulations - Stark

  • Productivity bonus changes
  • Period of disallowance
  • Indirect compensation arrangements
  • Physician compensation structures
  • Conditioning of referrals
  • Exclusivity of leases
  • Remuneration unrelated to DHS
  • Limited remuneration to a physician
  • Value-based exceptions
  • Cybersecurity technology exception

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Proposed Regulations - AKS

  • Outcomes-based payment
  • Warranties
  • Cybersecurity software and services
  • Transportation services
  • Care coordination to improve outcomes
  • Risk-based value arrangements

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Thank You

Stacy Harper, JD, MHSA, CPC Spencer Fane LLP. sharper@spencerfane.com 913-327-5120