Gifts to Referral Sources and Patients

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by Kim Stanger, Holland & Hart LLP

At this time of year, many healthcare professionals want to give gifts to patients, physicians, or other referral sources to show their appreciation, but doing so may violate federal and state fraud and abuse laws. Here are some guidelines to ensure your gift giving does not get you in trouble with the government.

1. Gifts To Referral Sources. The federal Anti-Kickback Statute (“AKS”) prohibits soliciting, offering, giving, or receiving remuneration in exchange for referrals for items or services covered by federal healthcare programs (e.g., Medicare and Medicaid) unless the arrangement fits within a regulatory exception. (42 USC 1320a-7b(b)). AKS violations are felonies, and may result in criminal and civil penalties, False Claims Act liability, and exclusion from Medicare and Medicaid programs. The AKS is violated if one purpose of the remuneration is to induce federal program referrals, including gifts to referring practitioners or program beneficiaries to encourage or reward their business. (OIG Adv. Op. 12-14). Moreover, the AKS applies to both the giver and recipient. The OIG has suggested that “nominal” gifts would not create much AKS risk, but offers no guidance as to what is “nominal”. (65 FR 59441). The AKS does not expressly apply to referrals for private pay business, but the OIG has warned that offering remuneration to obtain private pay referrals may also induce federal program business and thereby violate the AKS. (OIG Adv. Op. 12-06). In addition, offering gifts to induce or reward private pay business may violate state laws, including state laws prohibiting kickbacks, rebates, or fee splitting. In short, you should not give or accept gifts to or from referral sources (especially those referring federal program business) unless the gift is truly nominal, is clearly and completely unrelated to past or future referrals, or is very unlikely to influence referrals. Read more

OIG Issues Revised Self-Disclosure Protocol

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by Patricia (Pia) Dean, Holland & Hart LLP

On April 17, 2013, the Department of Health and Human Services Office of Inspector General released a revised provider self-disclosure protocol (SDP) that supersedes and replaces the 1998 Federal Register Notice and the Open Letters to Health Care Providers issued in 2006, 2008, and 2009. The SDP reaffirms the obligation on all members of the health care industry to take measures to detect and prevent fraudulent and abusive activities, and establishes new reporting requirements and guidance on calculating penalty multipliers.

Importance of Voluntary Self-Disclosure

The new SDP reaffirms the importance of self-disclosure, including OIG’s position that individual and entities that use the SDP and cooperate with OIG during the SDP process deserve to pay a lower multiplier on single damages than would normally be required. For the first time, the SDP states OIG’s general practice of requiring a minimum multiplier of 1.5 times the single damages, although the specific multiplier accepted may vary depending on the facts of each case.

CMS 60-Day Report and Repay Rule

The new protocol addresses CMS’s proposed 60-day “report and repay” rule. The Affordable Care Act generally requires that providers report and return Medicare or Medicaid overpayments within 60 days of the date the overpayment is first identified. Failure to report and repay within 60 days may create liability under the Civil Monetary Penalties Law (CMPL) and False Claims Act. CMS issued its proposed rule implementing the 60-day repayment obligation in February 2012. (77 FR 9179). The proposed rule would suspend the obligation to report overpayments when OIG acknowledges receipt of a submission on the SDP, provided the submission is timely made. In return for suspending the 60-day requirement, the new SDP states that OIG expects disclosing parties to disclose with a good-faith willingness to resolve all liability within the CMPL’s six-year statute of limitations. OIG has indicated it will provide additional guidance regarding the 60-day obligation and SDP process after CMS releases a final rule.

Eligibility Criteria and Guidance

The SDP provides greater guidance on how to investigate potentially fraudulent conduct, quantify damages, and report the conduct to OIG. According to the SDP, over the past 15 years, it has resolved over 800 disclosures, resulting in recoveries of more than $280 million to Federal health care programs. The SDP states that all health care providers, suppliers, or other individuals or entities that are subject to OIG’s civil monetary penalty authority are eligible to use the SDP. Accordingly, the SDP is not limited to any particular industry, medical specialty, or type of service. By way of example, the SDP states that a pharmaceutical or medical device manufacturer may use the SDP to disclose potential violations of the Federal anti-kickback statute (AKS) because such violations trigger CMP liability.

In addition, the new protocol delineates conduct that is not eligible for the SDP, including (1) matters that do not involve potential violations of Federal criminal, civil, or administrative law for which civil monetary penalties are authorized, such as one exclusively involving overpayments or errors, (2) requests for opinions from OIG regarding whether an actual or potential violation has occurred, and (3) disclosure of an arrangement that involves only liability under the physician self-referral law (Stark) without accompanying potential liability under the AKS for the same arrangement. Conduct that only involves Stark violations should be disclosed to CMS through CMS’s Self-Referral Disclosure Protocol.

Among other requirements, the SDP requires that the disclosing parties explicitly identify the laws that were potentially violated, and not just refer broadly to federal laws, rules and regulations. The SDP provides details for the content of all submissions as well as the specific requirements for conduct involving false billing, excluded persons, and the anti-kickback statute and physician self referral law.

The revised SDP is available here.

This publication is designed to provide general information on pertinent legal topics. The statements made are provided for educational purposes only. They do not constitute legal or financial advice nor do they necessarily reflect the views of Holland & Hart LLP or any of its attorneys other than the author. This publication is not intended to create an attorney-client relationship between you and Holland & Hart LLP. Substantive changes in the law subsequent to the date of this publication might affect the analysis or commentary. Similarly, the analysis may differ depending on the jurisdiction or circumstances. If you have specific questions as to the application of the law to your activities, you should seek the advice of your legal counsel.

May our group offer free screenings?

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by Kim Stanger, Holland & Hart LLP

As with other free or discounted items or services, offering free screenings can violate (1) the federal Anti-Kickback Statute (“AKS”) if one purpose of the free screening is induce referrals for items or services payable by federal healthcare programs (42 USC § 1320a-7b), and/or (2) the federal Civil Monetary Penalties Law (“CMP”) if the physician knows or should know that the free screening is likely to induce a federal program beneficiary to purchase items or services covered by federal healthcare programs (42 USC § 1320a-7a).  There are several potentially relevant CMP exceptions, most of which focus on whether the screening is tied to the provision of other services payable by federal healthcare programs.  In Advisory Opinion 09-11, the OIG approved a hospital’s free blood pressure screening program where (1) the free screening was not conditioned on the use of any other goods or services from the hospital; (2) the patient receiving the screening was not directed to any particular provider; (3) the hospital did not offer the patient any special discounts on follow-up services; and (4) if the screening was abnormal, the patient as advised to see their own health care professional.  Under these circumstances, the OIG concluded that the test was not improperly tied to the provision of other services by the hospital.

For more information, see the OIG’s Special Advisory Bulletin:  Offering Gifts and Other Inducements to Beneficiaries (August 2002), available at https://oig.hhs.gov/fraud/docs/alertsandbulletins/SABGiftsandInducements.pdf.

For questions regarding this update, please contact:
Kim C. Stanger
Holland & Hart, 800 W Main Street, Suite 1750, Boise, ID 83702
email: kcstanger@hollandhart.com, phone: 208-383-3913

This publication is designed to provide general information on pertinent legal topics. The statements made are provided for educational purposes only. They do not constitute legal or financial advice nor do they necessarily reflect the views of Holland & Hart LLP or any of its attorneys other than the author. This publication is not intended to create an attorney-client relationship between you and Holland & Hart LLP. Substantive changes in the law subsequent to the date of this publication might affect the analysis or commentary. Similarly, the analysis may differ depending on the jurisdiction or circumstances. If you have specific questions as to the application of the law to your activities, you should seek the advice of your legal counsel.

Paying for Call Coverage

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by Kim Stanger, Holland & Hart LLP

Hospitals increasingly pay physicians and other practitioners to participate in call coverage for emergency services. Last week, the Office of Inspector General (“OIG”) issued Advisory Opinion No. 12-15, which reminds providers of fraud and abuse parameters applicable to call coverage agreements.

Permissible Arrangements. Federal law does not require compensation for call coverage, nor does it prohibit paying for call so long as the compensation is not offered to improperly induce referrals for federal healthcare program business. The OIG recognizes that paying for call may be necessary to obtain services that may otherwise be unavailable because of, e.g., the lack of specialty services in an area or local physicians’ reluctance to take call because of practice demands, time commitments, or the probability of rendering uncompensated care. The key is to ensure that any call compensation paid (1) represents fair market value for actual and necessary services, (2) does not take into account the volume or value of referrals or other business generated between the parties, and (3) was not intended to maintain or generate future referrals from the physician for non-emergency patients. Common payment structures include hourly or “per diem” payments to be available for call, payment for time or services actually provided in response to call in exchange for assignment of the physician’s professional fees, etc.

 

Problematic Arrangements. Call compensation that exceeds fair market value or pays physicians for unnecessary or illusory services may amount to illegal kickbacks and/or Stark law violations. According to the OIG, suspect arrangements include:

  • “lost opportunity” or similarly designed payments that do not reflect bona fide lost income;
  • payment structures that compensate physicians even though no identifiable services are provided;
  • aggregate on-call payments that are disproportionately high compared to the physician’s regular medical practice income;
  • payment structures that compensate physicians for professional services for which the physician receives separate payments from patients or third party payors, thereby resulting in duplicate payment for the same services; or
  • payments made in response to threats that the physician will refuse to continue to use the hospital or refer non-emergency patients to the hospital unless call payments are provided.

Regulatory Compliance. Whatever its terms, the arrangement must be structured to satisfy Stark and Anti-Kickback Statute (“AKS”) technical requirements. For example, if the compensation is to be paid to a physician who is not employed by the hospital, the arrangement must satisfy the following:

  • The agreement must be documented in a written contract fully executed by the parties before any payments are made.
  • The compensation must represent fair market value for legitimate, needed services actually provided, and not offered to maintain, induce or reward the physician’s referrals to the hospital.
  • The compensation must not vary with the volume or value of referrals or other business generated by the physician except for services personally performed by the physician.
  • The compensation formula must be set in advance and be objectively verifiable.
  • Compensation-related terms may not change during the first year of the arrangement. If the agreement is terminated within a year, the parties may not enter a new agreement with different compensation terms within that year.
  • To avoid unintentional lapses, it is usually wise to include an auto-renewal or “evergreen” clause so that the agreement automatically renews unless terminated by the parties.

(See 42 C.F.R. §§ 411.357(d) and (l), and 1001.952(d)). Most call coverage arrangements will not satisfy an applicable AKS safe harbor because, e.g., the aggregate compensation is not set in advance. It is important that the parties consider and document the legitimate reasons for the call coverage arrangement, e.g., the hospital’s need for the contracted services, the financial or professional burden on physicians absent call compensation, and the physician’s reluctance to provide needed coverage absent call compensation that reflects fair market value for services actually provided.

For questions regarding this update, please contact:
Kim C. Stanger
Holland & Hart, 800 W Main Street, Suite 1750, Boise, ID 83702
email: kcstanger@hollandhart.com, phone: 208-383-3913

This publication is designed to provide general information on pertinent legal topics. The statements made are provided for educational purposes only. They do not constitute legal or financial advice nor do they necessarily reflect the views of Holland & Hart LLP or any of its attorneys other than the author. This publication is not intended to create an attorney-client relationship between you and Holland & Hart LLP. Substantive changes in the law subsequent to the date of this publication might affect the analysis or commentary. Similarly, the analysis may differ depending on the jurisdiction or circumstances. If you have specific questions as to the application of the law to your activities, you should seek the advice of your legal counsel.

Carving Out Federal Programs Does Not Preclude Anti-Kickback Liability

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by Kim C. Stanger, Holland & Hart LLP

The federal Anti-Kickback Statute (“AKS”) prohibits offering, paying, soliciting or receiving remuneration to induce referrals for items or services payable by federal health care programs unless the transaction fits within a regulatory safe harbor. 42 U.S.C. § 1320a-7b. AKS violations are felonies, resulting in penalties of $25,000 per violation and up to 5 years in prison in addition to civil penalties. AKS violations are now also False Claims Act violations, resulting in additional civil penalties.

To avoid AKS concerns, some transactions have been structured to carve out federal health care programs, e.g., remuneration is paid for non-Medicare or Medicaid business, but the remunerative arrangement does not apply to items or services payable by Medicare or Medicaid. The theory is that because the remuneration does not apply to federal healthcare programs, the AKS does not apply.

The Office of Inspector General (“OIG”) recently reaffirmed that such “carve out” arrangements do not necessarily protect the participants from AKS liability:

The OIG has a long-standing concern about arrangements under which parties “carve out” Federal health care program beneficiaries or business generated by Federal health care programs from otherwise questionable financial arrangements. Such arrangements implicate, and may violate, the anti-kickback statute by disguising remuneration for Federal health care program business through the payment of amounts purportedly related to non-Federal health care program business.

OIG Advisory Opinion No. 12-06 at p.6-7. Accordingly, the OIG declined to render a favorable opinion as to an arrangement that would have allowed certain payments for only those patients referred for non-federal program business.

Unless the transaction can fit within one of the AKS regulatory safe harbors in 42 C.F.R. § 1001.952, the test for an AKS violation remains whether “one purpose” of a transaction is to induce referrals for items or services payable by Medicare, Medicaid or other federal health care programs. United States v. Greber, 760 F.2d 68 (3d Cir. 1985), cert. denied, 474 U.S. 988 (1985). While carving out federal programs may help, it does not insulate participants from AKS violations. Healthcare providers and other potential referral sources or recipients may want to review any “carve out” arrangements to ensure that they truly satisfy the AKS.

For questions regarding this update, please contact
Kim C. Stanger
Holland & Hart, U.S. Bank Plaza, 101 S. Capitol Boulevard, Suite 1400, Boise, ID 83702-7714
email: kcstanger@hollandhart.com, phone: 208-383-3913

This publication is designed to provide general information on pertinent legal topics. The statements made are provided for educational purposes only. They do not constitute legal or financial advice nor do they necessarily reflect the views of Holland & Hart LLP or any of its attorneys other than the author. This publication is not intended to create an attorney-client relationship between you and Holland & Hart LLP. Substantive changes in the law subsequent to the date of this publication might affect the analysis or commentary. Similarly, the analysis may differ depending on the jurisdiction or circumstances. If you have specific questions as to the application of the law to your activities, you should seek the advice of your legal counsel.