AHLA. F. Anti-Kickback Primer. David E. Matyas Epstein Becker & Green PC Washington, DC

Transcription

1 AHLA F. Anti-Kickback Primer David E. Matyas Epstein Becker & Green PC Washington, DC Martha J. Talley Chief, Industry Guidance Branch Office of the Inspector General US Department of Health and Human Services Washington, DC Fraud and Compliance Forum September 27-29, 2015

2 Anti Kickback Primer Speakers: David Matyas Epstein Becker & Green Washington, DC Martha J. Talley Office of Inspector General, DHHS Washington, DC Agenda Overview of the Statute Exceptions and Safe Harbors Guidance Case Law Advisory Opinions Fraud Alerts and Advisory Bulletins Self Disclosures 2 1

3 OVERVIEW 3 Prohibition Prohibits the offering, paying, soliciting or receiving any remuneration in return for: Referral of patients; or Inducing, rewarding, arranging for, or recommending, purchases, leases, or orders Remuneration includes kickbacks, bribes and rebates, cash or in kind, direct or indirect Statute is broad and applies to anyone 4 2

4 Penalties Criminal and Civil Penalties $25,000 per offense Imprisonment up to 5 years Civil Money Penalties (exclusion and $50,000) 5 Health Reform Kickback = False Claim Previously, prosecutors and whistleblowers were required to bootstrap a claim that a kickback was connected to the submission of a false claim, such as through a certification of compliance Now, AKS specifically provides that a violation constitutes a false or fraudulent claim under the False Claims Act. Intent Requirement A person need not have actual knowledge of or specific intent to commit a violation of the AKS 6 3

5 EXCEPTIONS AND SAFE HARBORS 7 Statutory Exceptions Discount Exception Employee Exception Group Purchasing Organization Waivers of Certain Co Payments Risk Sharing Arrangements Safe Harbors Waivers of Part D Cost Sharing FQHCs Electronic Prescribing (See 42 USC (e)) Medicare Coverage Gap Discount Program 8 4

6 What are the Safe Harbors? Safe harbors provide immunity, but adherence is not required Failure to comply with a safe harbor can mean one of three things: arrangement does not fall within ambit of the statute; arrangement is obviously abusive, constitutes a clear statutory violation, and is very likely to be prosecuted; or arrangement involves risk because it may violate the statute in a less serious manner... 9 Timeline of Safe Harbor Issuances July 91 First 11 SHs Finalized Sept SHs Proposed Jan. 96 Managed Care SHs Finalized Nov SHs Finalized and Clarifications to First 11 SHs Nov. 99 Interim Final Risk Sharing SHs Dec. 01 Ambulance Restocking SH Sept. 02 Medicare SELECT Proposed Aug. 06 E Prescribing and EHR Final Oct. 07 FQHC Final Dec. 13 EHR Revisions Final Oct. 14 New Proposed SHs 10 5

7 General Investment Interest SHs Large Investment Interests Large publicly traded company registered with SEC At least $50 million in undepreciated assets Small Investment Interests 60/40 Investor Rule 60/40 Revenue Rule Investments in Entities in MUAs No Revenue Rule but 50/50 Investor Rule 75% of business derived from services furnished to persons in MUA 11 Personal Service, Equipment and Office Space Leases Written agreement for a term of at least one year Aggregate payment amount as well as the premises, equipment, or services covered must be specified If not full time services, agreement must specify schedule of intervals Compensation must be based on FMV and not vary based upon referrals or business 12 6

8 Fair Market Value Space Rental The value of the rental property for general commercial purposes, but does not vary on the volume or value of any Medicare covered or state healthcare program covered referrals or business otherwise generated between the parties OIG recommends an independent fair market valuation using appropriate health care valuation standards Equipment Rental The value of the equipment when obtained from a manufacturer or professional distributor, but does not vary on the volume or value of any Medicare covered or state healthcare program covered referrals or business otherwise generated between the parties Personal Services and Management Contracts Based on the value of an arms length transaction, but does not vary on the volume or value of any Medicare covered or state healthcare program covered referrals or business otherwise generated between the parties. 13 Discounts Statutory Exception discount or other reductioninpriceobtainedbyaprovider if the reduction is properly disclosed and appropriately reflected in the costs claimed or charges made by the provider or entity... Safe Harbor categorizes protection based upon the type of party involved in the transaction (buyers, sellers and offerors) and then further divides based upon the type of purchasing entity (MC/MA risk contractors, cost reporting entities, and all others (e.g., Part B suppliers)) 14 7

9 Ambulatory Surgery Centers 4 Categories of ASC Safe Harbors 1. Surgeon owned 2. Single specialty owned 3. Multi specialty owned 4. Hospital/Physician owned Special Requirements One Third Practice Income Test One Third/One Third Test (related to use of the ASC) 15 GUIDANCE 16 8

10 Advisory Opinions Provide advice on the application of the AKS and other OIG sanction authorities in specific factual situations Apply only to the requestor Published on OIG website Favorable opinions provide prospective immunity under the AKS 17 Searching Advisory Opinions 18 9

11 Choose Advisory Opinions in the Search Within Window 19 Other OIG Guidance Special Fraud Alerts and Special Advisory Bulletins Address fraud and abuse trends Compliance Program Guidance Organized by industry sector Other Guidance includes letters, policy statements, and other helpful resources 20 10

12 Case Law Greber one purpose test Hanlester specific intent to violate; but, ACA states person need not have knowledge of this [AKS] or specific intent to commit a violation of this section 21 SELF DISCLOSURE 22 11

13 Why Self Disclose? Reduced damages and/or penalties Less likelihood government will pursue criminal action or adverse administrative actions Decreased risk of whistleblower action Coordination among agencies to resolve selfdisclosed matters Demonstrates commitment to compliance 23 Avenues by which to Disclose OIG Voluntary Self Disclosure Protocol CMS Voluntary Self Referral Disclosure Protocol State Voluntary Self Disclosure Processes Department of Justice 24 12

14 OIG Voluntary Self Disclosure Protocol First published in 1998 to establish a process for health care providers to voluntarily identify, disclose, and resolve instances of potential fraud involving the Federal health care programs Subsequent open letters provided additional guidance Recently updated April, 2013 Past 15 years = recoveries of more than $280 million 25 Disclosure Importance and Benefits Emphasized the importance and benefits of voluntary disclosure [G]ood faith disclosure of potential fraud and cooperation with the OIG s review and resolution process are typically indications of a robust and effective compliance program. Presumption against requiring CIAs Confirmed lower multiplier generally a minimum of 1.5 Timing expedited resolution (less than 12 months from acceptance into protocol) Electronic submission new! 26 13

15 What Goes Into a Disclosure? Internal investigation and written submission General information related to provider Background and details related to conduct being disclosed Types of claims, period of noncompliance, relevant personnel and their roles What laws were violated Damages estimate, or quantification Corrective action Knowledge of government inquiry 27 Certification QUESTION AND ANSWER 28 14