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 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. Spencer Fane LLP | spencerfane.com Overview • Stark and Anti-Kickback Fact Analysis • Forest Park Case • Travel Act • EKRA • Proposed Regulations Spencer Fane LLP | spencerfane.com 1
12/17/2019 Fact Scenario • Physician Owned Hospital • Physician-owned landlord • Physician-owned staffing/administrative company • Physician-owned management company • Out-of-network all payers • Urban area Spencer Fane LLP | spencerfane.com Referring Physicians Ownership Ownership Ownership Real Estate Management Staffing Company Company Company Consulting Staffing Management Lease Ownership Agreements Agreement Agreement Hospital Spencer Fane LLP | spencerfane.com 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. Spencer Fane LLP | spencerfane.com 2
12/17/2019 Stark Law – Threshold Analysis • Physician (or immediate family member) • Financial Relationship • Referral • Designated Health Services • Medicare or Medicaid Spencer Fane LLP | spencerfane.com Stark Law - Physician – Medical Doctor (MD) – Doctor of Osteopathy (DO) – Dentist (DDS) – Podiatrist (DPM) – Optometrist (OD) – Chiropractor (DC) Spencer Fane LLP | spencerfane.com 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 Spencer Fane LLP | spencerfane.com 3
12/17/2019 Stark Law - Financial Relationship Compensation Investment Direct Indirect Stock, partnership shares, LLC Relationship is Relationship is Any remuneration memberships, between the through a chain of between the loans, bonds, and Physician (or the entities between physician and the other secured Physician’s Practice) the Physician and entity financial and the Entity the Entity instruments 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 or 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. Spencer Fane LLP | spencerfane.com 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 Home health services devices Outpatient prescription drugs Inpatient and outpatient hospital services Spencer Fane LLP | spencerfane.com 4
12/17/2019 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 Spencer Fane LLP | spencerfane.com Stark Law - Exceptions • Publically traded Securities • Payments by a Physician • Mutual Funds • Non-monetary compensation • Rural Providers • Fair Market Value Compensation • In-Office Ancillary • Risk-sharing Relationships • Physician Services • Compliance Training • Academic Medical Centers • Indirect Compensation • ASC Implants • Referral Services • Preventative Screening • OB Malpractice Subsidies • Eyeglasses and Contacts • Professional Courtesy • Rental Office Space • Retention Payments • Rental Equipment • Community-wide Health Information • Employment • E-Prescribing and Electronic Health Records • Personal Service Arrangements • Assistance for Non-physician Practitioner • Physician Recruitment • Timeshare Arrangements • Isolated Transactions • Certain Arrangements with Hospitals Spencer Fane LLP | spencerfane.com 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 Spencer Fane LLP | spencerfane.com 5
12/17/2019 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. Spencer Fane LLP | spencerfane.com 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. Spencer Fane LLP | spencerfane.com Referring Physicians Ownership Ownership Ownership Real Estate Management Staffing Company Company Company Consulting Staffing Management Lease Ownership Agreements Agreement Agreement Hospital Spencer Fane LLP | spencerfane.com 6
12/17/2019 Anti-Kickback Statute • Prohibits anyone from knowingly and willfully solicits or receives any remuneration, directly or indirectly, overtly 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 Spencer Fane LLP | spencerfane.com Anti-Kickback Statute – Threshold Analysis • Anyone • Remuneration • Referral, Purchase, Recommend • Item or Service • Federal Healthcare Program Spencer Fane LLP | spencerfane.com Anti-Kickback Statute - Anyone • Not limited to certain providers • Anyone involved in healthcare • Can be the patient him/herself Spencer Fane LLP | spencerfane.com 7
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