Stark/Anti- Kickback Fundamentals

Transcription

1 Stark/Anti- Kickback Fundamentals HEALTHCON Business Expo April 2016 Presented by: Stacy Harper, JD, MHSA, CPC 1 Disclaimer This presentation is for general education purposes only. The information contained in these materials and presented during the lecture or in response to your questions is not intended to be, and is not, legal advice or even particular business advice. The laws and regulations at issue in this lecture are open to interpretation. It is your responsibility to seek private counsel with your attorney to determine how these laws, regulations, policies discussed apply to your specific case before implementing the concepts addressed in this lecture. Attendance at this presentation should not be construed as creating an attorney-client relationship with the speaker, nor should the information presented be construed as legal advice. 2 Agenda Overview of the Laws Stark Anti-Kickback Review of Exceptions/Safe Harbors Enforcement and Oversight Self-Reporting 3 1

2 Overview of the Laws 4 Physician Self-Referral (Stark) 42 U.S.C. 1395nn Strict Liability Statute Prohibits submission of claims to a federal program if they were referred by a physician who has a financial relationship with the entity providing designated health service Several exceptions to the prohibition Must meet every element of an exception or there is a violation Submission of a claim in violation of Stark may also constitute a violation of the False Claims Act 5 Stark Key Definitions Physician means a doctor of medicine or osteopathy, a doctor of dental surgery or dental medicine, a doctor of podiatric medicine, a doctor of optometry, or a chiropractor, as defined in section 1861(r) of the Act. A physician and the professional corporation of which he or she is a sole owner are the same for purposes of this subpart. Immediate family member or member of a physician's immediate family means husband or wife; birth or adoptive parent, child, or sibling; stepparent, stepchild, stepbrother, or stepsister; father-in-law, mother-inlaw, son-in-law, daughter-in-law, brother-in-law, or sister-in-law; grandparent or grandchild; and spouse of a grandparent or grandchild. 6 2

3 Stark Key Definitions, continued Designated health services (DHS) means any of the following services (other than those provided as emergency physician services furnished outside of the U.S.), as they are defined in this section: Clinical laboratory services. Physical therapy, occupational therapy, and outpatient speech-language pathology services. Radiology and certain other imaging services. Radiation therapy services and supplies. Durable medical equipment and supplies. Parenteral and enteral nutrients, equipment, and supplies. Prosthetics, orthotics, and prosthetic devices and supplies. Home health services. Outpatient prescription drugs. Inpatient and outpatient hospital services. 7 Stark Key Definitions, continued Referral means the request by a physician for, or ordering of, or the certifying or recertifying of the need for, any DHS for which payment may be made under Medicare, including 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 DHS personally performed or provided by the referring physician. Financial Relationship Includes compensation arrangements and investment/ownership interests May be direct or Indirect (unbroken chain of persons/entities with financial relationships, knowledge of the chain, and aggregate compensation that varies with the volume or value of referral) 8 Anti-Kickback Statute 42 U.S.C. 1320a-7b Criminal Law Prohibits knowingly offering, soliciting, paying or receiving remuneration in exchange for a referral of healthcare services reimbursed by a federal healthcare program Applies to all people/entities and all items and services Government must show intent one purpose rule If arrangement meets a Safe Harbor, then guaranteed no liability Failure to meet Safe Harbor does not necessarily mean a violation 9 3

4 Anti-Kickback Key Definitions Remuneration includes kickbacks, bribes and rebates, cash or in-kind, direct or indirect Federal healthcare program means any plan or program that provides health benefits, whether directly, through insurance, or otherwise, which is funded directly, in whole or in part, by the United States Government; or any State health care program. 10 Exceptions and Safe Harbors 11 Exception AND Safe Harbor Available Investment Interests (very limited in scope) Lease of Office Space or Equipment Employment Personal Services Arrangement Physician/Practitioner Recruitment Referral Services EHR and E-Prescribing 12 4

5 Exceptions Under Stark Only In-Office Ancillary Personally Performed Services Whole Hospital and Rural Health Isolated Transactions Fair Market Value Medical Staff Incidental Benefits And More Safe Harbor Under Anti-Kickback Only Sale of Practice Warranties Discounts Group Purchasing Ambulatory Surgery Centers And More Analysis 15 5

6 Analysis under Stark Is there a referral by a physician for a designated health service payable by Medicare? Does the physician (or immediate family member) have financial relationship with the entity furnishing DHS? Does the financial relationship meet an exception? 16 Analysis under Anti-Kickback Which way is the referral going? Which way is the remuneration going? Is there an applicable Safe Harbor? Can additional safeguards be implemented? 17 Additional Guidance Available FAQs on CMS Website OIG Advisory Opinions OIG Fraud Alerts Case law 18 6

7 Enforcement Stark Enforced by CMS, OIG, and DOJ Exclusion from Federal Programs Recoupment of Payments Bootstrap False Claims Act Violation Anti-Kickback Enforced by OIG & DOJ Criminal and Civil Penalties Imprisonment up to 5 years Civil Penalties (exclusion and $50,000) 19 Self-Reporting 20 Self Reporting Options 60 Day Overpayment Requirement Final Rule issued in February, effective in March OIG Self Disclosure Protocol For violations that implicate the Anti-Kickback Statute or Civil Monetery Penalties CMS Stark Self-Disclosure Protocol When issue is limited to technical Stark violation 21 7

8 22 Physician Only For DHS Only DHS Entities Referring Physicians Strict Liability Summary Comparison Stark Knows or Should Know to add CMP Mandatory Exceptions Nonpayment, CMP, exclusion, FCA liability CMS non-payment OIG- CMP, exclusion DOG- FCA liability Types of Referrals Who Can be Liable? Necessary Intent Any Person or Entity Anti-Kickback Items or Services paid by any federal healthcare program Any Person/Entity Knowing and Willful Exceptions and Sanctions Enforcement Voluntary Safe Harbors Jail, criminal fines, CMP, exclusion, FCA liability OIG and DOJ Questions Stacy Harper, JD, MHSA, CPC Lathrop & Gage LLP