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  • Tuesday, April 26, 2016 7:39 AM | PAAW Administrator (Administrator)

    Upon reading this article, you will be able to answer the following questions.

    What is the Anti-Kickback Statute?
     
    Who is affected by the Anti-Kickback Statute?
     
    What are the penalties for a violation of the Anti-Kickback Statute?
     
    Are there any exceptions to a violation of the Anti-Kickback Statute?
     
    What can EMS providers do to help avoid a violation of the Anti-Kickback Statue?


    The Anti-Kickback Statute and Its Application to Private and Municipal EMS Providers

    As municipal departments become more involved in providing emergency medical services and inter-facility transports, discounts or provision of free services or items that result in charges below cost may trigger the federal Anti-Kickback Statute (“Anti-Kickback Statute”).  Because of the complexity of the Anti-Kickback Statute, EMS providers—whether privately owned or municipal—are encouraged to carefully evaluate proposed transactions and arrangements for fraud and abuse compliance.

    The Anti-Kickback Statute

    The Anti-Kickback Statute was enacted in 1972 to protect patients and federal health care programs from fraud and abuse.  The Anti-Kickback Statute makes it a criminal offense to knowingly and willfully offer, pay, solicit, or receive any remuneration to induce or reward referrals of items or services reimbursable by a federal health care program.  The statute assigns criminal liability to parties on both sides of an impermissible “kickback” transaction where the required elements are met, including that of intent.  For purposes of the Anti-Kickback Statute, “remuneration” includes the transfer of anything of value, directly or indirectly, overtly or covertly, in cash or in kind.

    Any person or entity in a position to generate federal health care program business for an ambulance supplier, directly or indirectly, is a potential referral source, including, but not limited to, 911 or equivalent emergency medical dispatch systems, responders, hospitals, nursing facilities, assisted living facilities, home health agencies, physician offices and patients.  EMS providers furnishing ambulance services may also be sources of patient referrals for hospitals, other receiving facilities, and second responders.

    Due to the broad range of transactions potentially implicated by the Anti-Kickback Statute, there are several statutory exemptions for certain types of payments, and the U.S. Department of Health & Human Services’ Office of Inspector General (“OIG”) has adopted certain “safe harbors” to exempt arrangements from the Anti-Kickback Statute, provided that they fall within parameters defined to minimize the risk for potential fraud and abuse.  Some of the safe harbors include: (1) ambulance restocking arrangements; (2) personal services and management contracts; (3) employees; (4) certain investment interests; (5) space rentals; (6) equipment rentals; and (7) discounts.

    OIG Advisory Opinions

    A request for an OIG Advisory Opinion may be requested by the parties to a proposed arrangement.  OIG’s response may offer insight into how it may view a particular transaction or arrangement under the Anti-Kickback Statute, but it may only be relied upon by the requestor(s) of the Advisory Opinion.  Also note that some Advisory Opinions speak to the lack of enforcement of an Anti-Kickback Statute violation, which is distinct from whether the arrangement itself presents an Anti-Kickback concern.  Below are some summaries of some relevant OIG Advisory Opinions.

    Ambulance Provider Discounts

    In a 1999 Advisory Opinion, an EMS provider proposed to provide inter-facility transports at a discount to a skilled nursing facility (“SNF”).  See Advisory Opinion 99-2 (Mar. 4, 1999), available at http://oig.hhs.gov/fraud/docs/advisoryopinions/1999/ao99_2.htm.  The EMS provider planned to charge Medicare for Part B transports at full Medicare rates.  In concluding that the proposed deal was not acceptable under the Anti-Kickback Statute, the OIG noted that arrangements providing discounts to potential referral sources that are also not provided to Medicare are suspect, especially where the discounts result in charges below the cost of providing services, or where discounted rates are only offered to those who also offer the opportunity for non-federal health care program business.  In other words, discounts that are below the ambulance provider’s cost or other types of discounts may independently give rise to an inference that the ambulance provider and the facility (such as a SNF) may be “swapping” discounts on Medicare Part A business in exchange for more profitable Medicare Part B business, from which the ambulance provider can recoup losses incurred on the discounted business potentially through overutilization or abusive billing practices.

    Municipal Arrangements for EMS Services

    Municipalities may provide EMS services through a local fire department or a private EMS company.  Because fraud and abuse issues may arise in an arrangement with a municipality, all EMS providers are encouraged to carefully evaluate proposed arrangements for compliance with the Anti-Kickback Statute.  Examples of issues that EMS providers have sought guidance on from OIG include whether copays or deductibles may be waived by an EMS provider, and whether services or items may be provided at or below cost.

    In 2001, a municipal fire department that owned and operated an ambulance service requested an advisory opinion from OIG regarding whether its treatment of local taxes as payment of EMS transport copayments and deductibles violated the Anti-Kickback Statute. The fire department provided emergency medical services free of charge to residents and did not bill the residents or their insurers; however, the fire department billed non-residents and their insurers for EMS.  The fire department sought OIG guidance as to whether it could bill its residents and their insurers only to the extent of their insurance coverage (commonly referred to as “insurance only” billing), including federal health care programs, and whether it could treat the revenues received from local taxes as payment of copayments and deductibles otherwise owed by residents.  The OIG stated that the proposed insurance only billing by a state or local government entity, such as a municipal fire department, is not viewed as furnishing free services.  Accordingly, since Medicare does not require the fire department to collect copayments or deductibles from residents, OIG concluded that the arrangement did not violate the Anti-Kickback Statute.  See Advisory Opinion 01-10 (July 20, 2001), available at http://oig.hhs.gov/fraud/docs/advisoryopinions/2001/ao01-10.pdf.

    In another 2001 Advisory Opinion, the OIG found a similar arrangement potentially impermissible and subject to sanctions under the Anti-Kickback Statute because it differed in one significant respect:  the municipality was contracting with a private EMS company for the provision of services to residents, rather than providing the services itself.  In this Advisory Opinion, the municipality required the private ambulance company to waive copayments and deductibles, including those for Medicare, for residents and the OIG found that this could violate the Anti-Kickback Statute.  See Advisory Opinion 01-12 (July 20, 2001), available at http://oig.hhs.gov/fraud/docs/advisoryopinions/2001/ao01-12.pdf.

    OIG, in a 2006 Advisory Opinion, found that an exclusive arrangement between a city and an EMS provider to provide non-emergency inter-facility ambulance transport services presented low risk of fraud or abuse of federal health care programs.  The EMS provider proposed to pay the city an annual set fee of $50,000 that would partially offset the city’s costs of operating inter-facility dispatch services and of monitoring/supervising of the ambulance provider’s inter-facility transport services.  The OIG found that the risk of fraud and abuse was low since the proposed arrangement was not likely to increase federal health care program costs, would not result in steering of business since patients were being transported between prearranged facilities, and the arrangement served the public, rather than private interests.  See Advisory Opinion 06-12 (Sept. 25, 2006), available at http://oig.hhs.gov/fraud/docs/advisoryopinions/2006/Adv-Opn06-12B.pdf.

    A 2013 OIG Advisory Opinion concluded that an EMS provider’s response to a city’s RFP for an exclusive contract for ambulance and inter-facility transport services potentially could violate the Anti-Kickback Statute due to its inclusion of items or services at no charge or nominal value, such as free defibrillators and free EMS training and classes for city personnel.  This Advisory Opinion serves as a reminder for ambulance companies to be on the lookout for potential inducements in RFPs and contracts—particularly ones that call for free or discounted items or services to be provided by the ambulance company to the municipality as a condition of being awarded the contract.  See Advisory Opinion 13-18 (Nov. 21, 2013), available at http://oig.hhs.gov/fraud/docs/advisoryopinions/2013/AdvOpn13-18.pdf.

    Penalties for Anti-Kickback Violations

    Criminal penalties for violating the Anti-Kickback Statute may result in fines up to $25,000 and imprisonment for up to five (5) years per violation.  See 42 U.S.C. § 1320a-7b(b).  Criminal conviction also results in mandatory exclusion from participation in federal health care programs.  See 42 U.S.C. § 1320a-7(a).  Even absent a criminal conviction, individuals who violate the Anti-Kickback Statute may still face exclusion from federal health care programs at the discretion of the Secretary of Health and Human Services.  See 42 U.S.C. § 1320a-7(b).

    The government may also assess civil money penalties for violation of the Anti-Kickback Statute.  Civil penalties may result in treble damages plus $50,000 per violation.  See 42 U.S.C § 1320a-7a(a)(7).   False Claims Act liability may also be implicated.  Although the Anti-Kickback Statute does not afford a private right of action, a violation of the Anti-Kickback Statute serves as a vehicle whereby individuals may bring qui tam actions.  See 31 U.S.C. §§ 3729–3733.

    Potential transactions and arrangements involving EMS providers and other entities—whether they are municipalities or private health care providers—pose opportunities for growth and improved patient quality of care, but may also face an increased risk of scrutiny due to the regulated nature of health care and the Anti-Kickback Statute.  A robust compliance plan and employee training, coupled with careful review of any proposed transactions and arrangements (including, if necessary, working with legal counsel to seek guidance or an OIG Advisory Opinion) may help ensure that your company does not get tripped up by an unintentional violation of the Anti-Kickback Statute.

    For additional assistance or to have your individual questions answered, contact attorney Wendy Arends at 608-257-3911.


    The April 26, 2016 EMS Live in Wisconsin podcast interviewed attorney Wendy Arends about the Anti-Kickback Statute as it relates to private and municipal ambulance services.  >> Click to listen now.


    About the Authors

    Thomas Shorter is a shareholder in the firm's Madison office and Chair of the Health Care Team. Tom represents hospitals, physicians' groups, research institutions and health care related organizations, as well as other businesses, providing counsel on health care, corporate, labor and employment and regulatory matters.

    For clients in the health care industry, Tom handles matters regarding Medicare compliance, Health Insurance Portability and Accountability Act (HIPAA), Emergency Medical Treatment and Labor Act (EMTALA), Physician Self-Referral (Stark), and Anti-Kickback.

    Additionally, Tom is also called upon by other organizations to handle management-side legal corporate and employment issues, including the Family and Medical Leave Act (FMLA), Fair Labor Standards Act (FLSA) compliance, Individuals with Disabilities Education Act (IDEA), Section 504, and Americans with Disabilities Act (ADA).


    Wendy Arends is a senior associate in the firm’s Madison office where she advises businesses, organizations and trade associations regarding their interactions with local, state and federal government. Her practice focuses on matters involving antitrust and consumer protection, health care, and international trade compliance. Prior to joining Godfrey & Kahn, Wendy practiced for more than four years at a large national law firm in Washington, D.C. where she worked on a variety of complex commercial litigation and regulatory matters.

  • Monday, April 18, 2016 7:23 AM | PAAW Administrator (Administrator)

    More than 800 Wisconsinites died of prescription narcotic painkiller and heroin overdoses in 2013, the most recent year for which there is data available, and drug overdose is now the leading cause of injury death in the United States.

    The Professional Ambulance Association of Wisconsin and Wisconsin Attorney General Brad Schimel teamed up to announce details of a new rebate program for Naloxone, the opiate antidote, that will be administered by the Wisconsin Department of Justice for qualifying organizations.  Wisconsin ambulance services are eligible to apply for the rebate. 
    >> Click for more information.

  • Wednesday, April 13, 2016 7:29 AM | PAAW Administrator (Administrator)

    EMS Live in Wisconsin Podcast

    >> Click to listen now!

    This EMS Live in Wisconsin podcast was recorded on Tuesday, April 12.

    The program began with an announcement regarding a $6.00 rebate negotiated between Wisconsin Attorney General Brad Schimel and Naloxone (Narcan) manufacturer Amphastar.  Wisconsin ambulance services are eligible, but must file their rebate within 60 days of each quarter's end.  The Agreement expires February 1, 2017.  For more on the rebate program, go to >> http://paaw.us/Amphastar-narcan-rebate.

    The second part of the program, starting at 6:00 minutes, included a discussion on stemi drug therapy with guests Dr. Michael Rosenberg, Medical Director-Cardiovascular Services, Holy Family Memorial Hospital, Manitowoc, Valders Ambulance Director Jay Steuer, and Baraboo Area Ambulance Chief Dana Secular.  Holy Family Memorial Hospital was recently named one of 50 top hospitals in the nation regarding its stemi EMS system.

  • Monday, April 11, 2016 6:26 AM | PAAW Administrator (Administrator)

    An emergency room clogged with patients is an unwelcome sight for everyone involved — patients, doctors and other caregivers alike.

    Hospitals responded in the past by sending incoming ambulances to other hospitals, sometimes 10 to 15 critical minutes away.

    But under a policy that took effect this month, hospitals in Milwaukee County are no longer allowed to divert ambulances when their emergency departments have a high volume of patients.

    "We needed to do better for the patients," said M. Riccardo Colella, director of medical services for the Milwaukee County Office of Emergency Management.
      >> Click to read more...

  • Saturday, April 02, 2016 8:55 AM | PAAW Administrator (Administrator)

    “501 please respond for a male subject who is turning yellowish-orange”

    “Copy, 501 en route”

    Two females seated in kitchen, one teary. 40s male seated on couch, Mt Dew at hand and completely unconcerned. Denies any symptoms, no medical history of any kind, no medications, and no desire to be seen in the ER.

    Wife, brow furrowed; “maybe it’s because I haven’t seen him in daylight in so long”

    Mother in law, bent forward with hands on hips, nose inches from patient’s face, inspecting his eyes; “what you maybe need is to go out on the deck and just have a cigarette in the sunlight”

    Neighbor arrives, hugs wife tearfully, says to fire personnel; “last time I was catatonic I was going thru my friend’s drawers, almost pulled out my nose ring. That was after I had the grand mal and then went tonic clonic.”

    Wife, helpfully; “he isn’t even a drug user!”  >> Click to read more...


    "Standby for Tones" is a monthly blog written by Crystal Wallin, a La Crosse paramedic.  Her stories, written from real life events, bring to light the human experience in having an EMS career and work life.  >> Click to read Crystal's blog.
  • Wednesday, March 23, 2016 10:08 PM | PAAW Administrator (Administrator)

    PAAW influential in bringing discount to Wisconsin

    Standing alongside members of the Professional Ambulance Association of Wisconsin (PAAW), Attorney General Brad Schimel announced on March 23 details of a rebate program for the heroin and prescription opioid antidote naloxone, also known as Narcan.

     
    “Heroin and prescription narcotic painkillers are contributing to more deaths in Wisconsin each year than car crashes,” said Attorney General Schimel. “The Wisconsin Department of Justice is doing, and will continue to do, everything it can to make access to naloxone as easy and cheap as possible.”
     
    Amphastar Pharmaceuticals has agreed to provide a $6 rebate for each Amphastar naloxone syringe purchased by public entities in Wisconsin from now until February 1, 2017. Amphastar Pharmaceuticals has reached similar agreements with other states, including Ohio and New York.  PAAW brought these similar state agreements to Attorney General Schimel's attention, which led impart to Wisconsin crafting a rebate with the manufacturer.
     
    “Naloxone, often branded as Narcan, can be administered as a nasal spray or injection and works within minutes to reverse the effects of an opioid overdose,” said Patrick Ryan, President of the Professional Ambulance Association of Wisconsin (PAAW). “Our public safety and EMS partners across Wisconsin are incredibly grateful for the Amphastar naloxone rebate agreement and believe it will increase access and use of this lifesaving drug, especially when mere minutes could be the difference between life and death once an emergency responder arrives on the scene of an overdose.”

    State, county, and local government agencies, as well as law enforcement and other public and government entities that distribute naloxone are eligible for the Amphastar naloxone rebate.
     
    The Wisconsin Department of Justice is also exploring rebates with other manufacturers of naloxone.
     
    Naloxone rebate instructions and all necessary forms are available below.
     
    >> Amphastar Pharmaceuticals, Inc. Contract
    >> Naloxone Rebate - Press Release
    >> Naloxone Rebate Instructions
    >> Naloxone Account Form
    >> Naloxone Purchase Summary

    Announcement Media Coverage
    >> Wisconsin State Journal, Madison
    >> WBAY-TV, Green Bay
    >> Fox 6-TV, Milwaukee
    >> WKOW-TV, Madison
    >> WISC-TV/Ch. 3000, Madison
    >> WMTV-TV, Madison
    >> Wheeler Report, Wisconsin Representative Nygren
  • Thursday, March 17, 2016 1:27 PM | PAAW Administrator (Administrator)

    >> Click to listen to this audio webcast.

    Last year was a busy year for EMS at the state capitol with three bills passing the Senate and Assembly and ultimately being signed into law by Governor Scott Walker.  New laws that quickly come to mind include the Tax Refund Interception Program (TRIP) spearheaded by PAAW, as well as laws allowing First Responders to operate as one member of a two-person legal ambulance crew, and cross border mutual aid and coverage agreements.

    In July 2015 James Newlun took the helm as the State of Wisconsin EMS Director. 

    James oversees the state’s EMS Office, which is truly the nerve center for anything and everything EMS.  There are a lot of moving parts that include review of operation plans, event plan approvals and individual, provider and training center licensing requests and renewals.  Wisconsin is a large and robust statewide EMS delivery system that includes over 800 ambulance services and first responder groups and 22,000 licensed individuals.

    Recently, PAAW Executive Director Joe Covelli had the opportunity to discuss with James two memos his office released in January about First Responders and mutual aid and coverage agreements.  He’s also working to streamline the way ambulance operation plan changes are submitted to the state.  Once launched in the coming months, the new approach will avoid delays and just be more efficient.

    >> Click to listen to this audio webcast.
  • Friday, March 11, 2016 8:16 AM | PAAW Administrator (Administrator)

    “307 please respond for an 85yr old female, chest pain, one nitro taken”

    “307 copy, updated en route”

    The address is located on a main thoroughfare and the fire rescue at the curb marks the spot. Generally we try to do our backing as we arrive, utilizing our partner for spotting then rather than at time of leaving. This ensures safe backing practice, since one of us will be with the patient as we leave the scene.  >> Click to read more...


    "Standby for Tones" is a monthly blog written by Crystal Wallin, a La Crosse paramedic.  Her stories, written from real life events, bring to light the human experience in having an EMS career and work life.  >> Click to read Crystal's blog.

  • Tuesday, March 08, 2016 3:46 PM | PAAW Administrator (Administrator)
    The Wisconsin EMS Office recently published two important memos and helpful checklist information for Scope of Practice and Medication List.

    >> EMS Numbered Memo 16-01 describes how a service can add First Responders to function as a member of a legal crew for the service.

    >> EMS Numbered Memo 16-02 explains the difference between Mutual Aid and Coverage Agreements. Each has its specific purpose and one should not be used for both situations.


    Helpful Checklists

    >> Wisconsin Scope of Practice
    >> Medication List
  • Tuesday, March 08, 2016 10:39 AM | PAAW Administrator (Administrator)

    We switch gears and also discuss EMS Roaddocs

    >> Click to listen to this podcast.

    On Tuesday, March 8 EMS Live in Wisconsin discussed recent virus and bacteria outbreaks.  The Wisconsin Department of Health Services  is currently investigating into an outbreak of bloodstream infections caused by bacteria called Elizabethkingia.  The Elizabethkingia infection has been detected in 44 patients located in southeastern and southern Wisconsin.  >> Click for full details.

    What risks do EMS responders have with the Elizabethkingia bacteria?  What are the presenting signs and symptoms?  What safety precautions or recommendations should be taken?  What patients are at risk?

    We also discussed the Zika Virus that is receiving national and international attention.  The good news here is mosquitoes found in Wisconsin are not the same ones identified as a carrier of the Zika Virus.

    Our guest on EMS Live Podcast was Stephanie Smiley, Director of Bureau of Communicable Diseases for the State of Wisconsin's Division of Public Health.

    In addition, 20 minutes into the program we were joined by Justin Foley, who is a member with EMS Roaddocs, a motorcycle riding club in Wisconsin and Northern Illinois.  EMS Roaddocs is made up entirely of full and part time people who work in emergency services, either active or retired, that includes doctors, nurses, paramedics, EMT’s and Firefighters.

    >> Click to listen to this podcast.

    Next EMS Live in Wisconsin Podcast March 22

    Join us Tuesday, March 22 for the next EMS Live program starting at 9:00 a.m. and lasting 30 minutes.  Our guests include Wisconsin DEA Supervisor Kathy Frederico and American Ambulance Association VP of Government Affairs Tristan North.  The US House of Representatives is considering legislation that impacts every ambulance service that carries controlled narcotics.  Dial into the program at 646-929-1081, or listen on any internet connected device at http://tobtr.com/8398779.

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