DRAFT: This module has unpublished changes.

Law and Policy

 

Key Competencies:

Communication and Relationship Management—

Interpersonal communication and writing skills

Working in teams

 

Business Skills and Knowledge—

Solving problems and making decisions

Organizational dynamics and governance

 

Professionalism—

Professional and community contribution

 

Healthcare Knowledge—

Healthcare issues and trends

Health policy formulation, implementation, and evaluation

Syllabus:

 

Health Law and Policy_syllabus.pdf

 

My Development:

 

As a paralegal coming into this course with a solid background in law and policy as it relates to healthcare, I was pleased to walk away having learned so much.  Our discussions around Stark and Anti-Kickback greatly reinforced my knowledge base.  One exercise we completed to analyze the two important federal statutes resulted in the following tool on Anti-Kickback that I expect to modify as needed and use in the future:

 

 

Federal Anti-Kickback Statute

 

Purpose – protect patients and Federal health care programs from fraud and abuse

 

Further, the anti-kickback statute is a criminal prohibition against payments (in any form, whether the payments are direct or indirect) made purposefully to induce or reward the referral or generation of Federal health care program business. The anti-kickback statute addresses not only the offer or payment of anything of value for patient referrals, but also the offer or payment of anything of value in return for purchasing, leasing, ordering, or arranging for or recommending the purchase, lease, or ordering of any item or service reimbursable in whole or in part by a Federal health care program. The statute extends equally to the solicitation or acceptance of remuneration for referrals or the generation of other business payable by a Federal health care program. Liability under the anti-kickback statute is determined separately for each party involved. In addition to criminal penalties, violators may be subject to CMPs and exclusion from the Federal health care programs. Hospitals should also be mindful that compliance with the anti-kickback statute is a condition of payment under Medicare and other Federal health care programs. 

Source: Appendix 56. HHS Supplemental Compliance Program Guidance for Hospitals.  Retrieved from Westlaw on April 18, 2016.

Important Elements to remember:

 

□   The arrangement cannot vary with the volume or value of referrals

□   As of 1980 – requires intent

□   Criminal implications

□   As of 1987 – added exclusion authority from Medicare and state healthcare programs

□   Extends equally to the solicitation or acceptance of remuneration for referrals

□   If any “one purpose” of a transaction is to induce referrals, a violation has occurred.

 

 

The Federal Anti-Kickback Statute prohibits the knowing and willful solicitation, offer, payment or acceptance of 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 party under a federal healthcare program; or
  • 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 party under a federal healthcare program

This is a BROAD statute and many arrangements are implicated therefore Safe Harbors have been established to provide protection.  Your legal department can interpret the arrangement you wish to enter and determine if it will come under one of the following Safe Harbors:

 

Safe Harbors:

 

  • Investment interests
  • Space rental
  • Equipment rental
  • Personal services and management contracts
  • Sale of practice
  • Referral services
  • Discount
  • Employee
  • GPO
  • Waiver of beneficiary coinsurance and deductible amounts
  • Practitioner recruitment safe harbor
  • Obstetrical malpractice insurance subsidies
  • Cooperative hospital service organizations
  • Ambulatory surgical centers
  • Ambulance replenishing

*there are also certain safe harbors for certain managed care and risk sharing arrangements

Source: Appendix 56. HHS Supplemental Compliance Program Guidance for Hospitals.  Retrieved from Westlaw on April 18, 2016.

 

What to consider when contracting:

 

□   Start by assuming the arrangement falls within the purview of the Anti-Kickback statute

□   Put the agreement in writing

□   Have all parties sign agreement

□   Set the term for a minimum of 1 year

□   Compensation must be FMV and set in advance (you can’t decide a month after you sign an agreement that you really wanted to pay 2k rather than 1k)

 

 

DRAFT: This module has unpublished changes.