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Posts Tagged ‘Safe Harbor Regulations’

Ambulatory Surgery Centers – Federal Settlement Highlights Safe Harbor Requirements

Monday, September 29th, 2014

ASC Investments Safe HarborsA Tennessee based ambulatory surgery center company has agreed to pay damages to a former employee who filed a suit alleging that physician investments in local surgery center entities violated the Anti-kickback Statute.  The case highlights some of the unique kickback issues that are present in ambulatory surgery center structure.  Specifically, the case demonstrates how investment terms that are intended to assure compliance with the safe harbor regulations under the Medicare Anti‑Kickback Statute (42 U.S.C. § 1320a-7b(a)-(b)) can create evidence of non-compliance if the initial terms of the offering relate, in whole or in part, to the volume or value of expected referrals from the investor in the ASC venture.

In order to comply with safe harbor requirements, ASCs must generally require investing physicians to use the facility as an extension of their medical practices.  However, if the terms of the investment are based on the volume or value of referrals, those same requirements become evidence that referrals are being required in exchange for remuneration.  In the Tennessee case, the ASC management company purchased controlling interests in local surgery center entities at a high multiple of earnings.  Physicians who were referral sources were offered investments at less than 1/3 of the value that was applicable to the non-referring management company.  That differential in value was evidence of “remuneration” under the Anti-kickback Statute and also indicated that investment terms were more advantageous based on expected referrals.

Structuring ambulatory surgery center investments to comply with Anti-kickback requirements is an extremely complex task.  Indications of compliance can become evidence of non-compliance depending on initial investment terms.  Cases such as the Tennessee case illustrate the problems that can occur when safe harbor requirements are not complied with and when decisions on investment or exclusion are made based on past or anticipated referrals.  The Tennessee case also illustrates how these issues come to light.  The Tennessee case was filed as a whistleblower case by a former administrator of one of the local surgery centers who walked away with a settlement in the millions of dollars.

We have published a more complete analysis of the Tennessee case which you can access through the following link   ASC-Investment-Federal-Case

Block Leasing of Group Practice Facilities – Anti-Kickback Statute Risks

Friday, October 18th, 2013

Block Leasing of Ancillary Services – Risks Under The Anti-Kickback Statute

Block Lease Anti-kickback StatutePhysician groups will often look for ways to share the expenses of excess capacity of high cost center ancillary services.  One approach that is sometimes considered is leasing the ancillary center to another physician group. 2009 changes to the Stark Regulations established new requirements for part-time leasing arrangements.  ”Per use” arrangements are now prohibited under the Stark Law which applies when the ancillary service is categorized as a designated health service under the Stark Law.  Comments to the 2009 Stark Regulations maintained an opening to permit some  ”block leasing” or “time sharing” arrangements.  CMS left open the parameters that must be met making compliance a bit tricky.  But block leasing arrangements are at least possible in theory under the Stark Law.  Until a few years back, block leasing arrangements were a relatively common way to permit separate physician groups to, in effect, share an ancillary service line. An OIG Advisory Opinion that was issued in 2010 cast a significant shadow on block leasing arrangements; including those arrangements that previously appeared to be legitimated under the Stark Law.  The 2010 Advisory Opinion refused to endorse a block leasing arrangement between two physician groups.

OIG Advisory Opinion 08-10, an oncology group asked the OIG to approve a block lease of  a radiation therapy facility to various different urology groups.  The block lease included all equipment, facility, and staff necessary for the urology group to provide radiation therapy services for their own patients.  The block leasing arrangements were structured in a manner suggested by CMS comments to be legitimate under the Stark Law.   Even though the arrangement likely complied with the Stark Law, the OIG raised concern and refused to endorse the arrangement under the Anti-Kickback Statute.  The OIG expressed concern that the block lease was nothing more than a  vehicle to permit the urology groups to profit from their referrals for radiation therapy services.  The OIG seemed to focus on many of the same factors that it had previously identified in joint venture arrangements.  For example, the OIG pointed to the fact that the oncology group was an existing provider of radiation therapy services and that the urology group was a natural referral source for those services.  Viewed from this angle, the OIG considered the block leasing arrangement to be nothing more than a cleaver way to compensate the urology group for its referrals.

The OIG noted that the opportunity for the urology groups to profit from radiation services amounted to “remuneration” under the anti-Kickback Statute.  The OIG looked past the fact that at least part of the arrangement complied with a safe harbor and instead focused on the overall “big picture” of the arrangement.

Advisory Opinion 08-10 related to a radiation therapy center.  The reasoning in 08-10 applies equally to all types of ancillary services.  Because the OIG’s concerns arise from the Anti-Kickback Statute, the concept is not limited to “designated health services” under the Stark Law.  Leasing any ancillary service and providing the opportunity for a physician group to profit from billings for that service are called into question by the opinion.

Ambulatory Surgery Center Safe Harbor Regulations

Friday, July 15th, 2011

Ambulatory Surgery Center – Anti-kickback Issues and Safe Harbor Regulation Compliance

Ambulatory Surgery Center StructuresMore and more procedures are being performed in Ambulatory Surgical Centers. The CMS has recently expanded the procedures that it considers to be safely performed in an ASC. Clearly, the trend is to move many procedures to an outpatient facility unless the health care needs of the patient clearly require an inpatient presence. One of the primary sources of capital for these new ASC ventures is often the physicians who are involved in performing procedures in the ASC or sending business to the ASC. From a purely business point of view, it makes sense to have investors who have a direct financial interest in seeing that the business succeeds, However, from the point of view of the party paying for the care, this same financial interest can lead to an increased and arguably unnecessary levels of procedures performed in the facility. The Medicare and Medicaid program, and many states, have enacted the Anti-kickback Statutes and other anti-referral laws that prohibit, or at least limit, the financial interests that a referring provider can have with an organization where there is any control over the referral flow to that entity.

Anti-Kickback Statute Prohibition

This is where the Federal Anti-kickback Statute comes into play by prohibiting the payment of any form of remuneration between parties where referrals are involved. The federal Anti-Kickback Statute proscribes the offering, payment, solicitation or receipt of any remuneration in exchange for a patient referral or referral of other business for which payment may be made by any Federal health care program. Violations of the Anti-Kickback Statute is a federal felony and can result in substantial prison time and criminal monetary penalties. Violation of the Anti-Kickback Statute can also serve as a basis for imposition of Civil Monetary Penalties. Enforcement of the Federal Anti-kickback Statute has been on the rise since the mid-1980s. Today, the federal government has made health care fraud one of its top priorities. We are hearing about new prosecutions on an almost daily basis as the government ramps up its enforcement through the creation of the HEAT program.

ASC Ownership and the Federal Anti-Kickback Statute

When we look at a typical Ambulatory Surgical Center venture, the primary concern is when the physicians who make referrals to the entity and provide services in the entity receive remuneration from the entity, This normally will involve remuneration in the form of a return on an investment interest. The referring physician may purchase an ownership or investment interest in the company that is set up to operate the ASC.  The ASC can be set up with capital contributions from a number of physicians or it may involve a hospital sponsored ASC that seeks additional capital investment from physicians.

Regardless of the exact structure, the Anti-kickback Statute will come into play to govern the structure and ongoing operation of the ASC. The ASC venture must be structured from the start to comply with the Anti-Kickback Statute. It must also be monitored on an ongoing basis to assure that it does not fall out of compliance with the Anti-Kickback Statute.

Can Private Health Care Be Carved Out of Anti-kickback Application?

Monday, June 13th, 2011

Anti-Kickback Statute Advisory Opinion Clarifies

Medicare Carve Out Does Not Insulate Payment Arrangement

The anti-kickback statute makes it a criminal offense knowingly and willfully to offer, pay, solicit, or receive any remuneration to induce or reward referrals of items or services reimbursable by a Federal health care program. Where remuneration is paid purposefully to induce or reward referrals of items or services payable by a Federal health care program, the anti-kickback statute is violated, By its terms, the statute ascribes criminal liability to parties on both sides of an impermissible “kickback” transaction, , 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.
Clients often ask whether the Anti-kickback Statute covers payment arrangements that do not involve a Federal Health Care program.  In other words, the question is whether Federal Health Program beneficiaries can be “carved out” of the payment arrangement so that the Anti-kickback Statute is not applicable to the proposed financial arrangement.  The answer to this question is…..wait for it….no.  You cannot get around the Anti-kickback Statute by carving out Federal Health Care Programs from your payment arrangement.

This was confirmed by the Office of Inspector General in a recent Advisory Opinion regarding an arrangement between a DME Supplier of continuous positive airway pressure blower units, masks and supplies and an Independent Diagnostic Testing Facility.  The arrangement originally was structured to “carve out” Federal Health Care beneficiaries from the payment arrangement.  The OIG rather clearly found that “carve out” arrangements do not protect and arrangement from scrutiny under the Anti-kickback Statute.  The OIG’s wording best describes the reasoning behind this finding:

The Existing Arrangement covers services provided to non-Federally insured patients only,. Thus, as a threshold matter, we must address whether the “carve out” of Federal business is dispositive of the question of whether the Existing Arrangement implicates the anti-kickback statute, It is not. The OIG has a long-standing concern about arrangements pursuant to 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 business through the payment of amounts purportedly related to non-Federal business. Here, IDTFs participating in the Existing Arrangement may still influence referrals of Federal health care program beneficiaries to the Requestor for DME. Thus, we cannot conclude that there would be no nexus between the Requestor’s payments to the IDTF for services provided to non-Federal patients and referrals to the Requestor of Federally insured patients.

OIG Advisory Opinion Addresses Medicare Carve-Outs and Antit-kickback Statute

Monday, June 6th, 2011

Anti-Kickback Statute Advisory Opinion Clarifies

Medicare Carve Out Does Not Insulate Payment Arrangement

The anti-kickback statute makes it a criminal offense knowingly and willfully to offer, pay, solicit, or receive any remuneration to induce or reward referrals of items or services reimbursable by a Federal health care program. Where remuneration is paid purposefully to induce or reward referrals of items or services payable by a Federal health care program, the anti-kickback statute is violated, By its terms, the statute ascribes criminal liability to parties on both sides of an impermissible “kickback” transaction.  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.

Clients often ask whether the Anti-kickback Statute covers payment arrangements that do not involve a Federal Health Care program.  In other words, the question is whether Federal Health Program beneficiaries can be “carved out” of the payment arrangement so that the Anti-kickback Statute is not applicable to the proposed financial arrangement.  The answer to this question is…..wait for it….no.  You cannot get around the Anti-kickback Statute by carving out Federal Health Care Programs from your payment arrangement.

 This was confirmed by the Office of Inspector General in a recent Advisory Opinion regarding an arrangement between a DME Supplier of continuous positive airway pressure blower units, masks and supplies and an Independent Diagnostic Testing Facility.  The arrangement originally was structured to “carve out” Federal Health Care beneficiaries from the payment arrangement.  The OIG rather clearly found that “carve out” arrangements do not protect and arrangement from scrutiny under the Anti-kickback Statute.  The OIG’s wording best describes the reasoning behind this finding:

 The Existing Arrangement covers services provided to non-Federally insured patients only,. Thus, as a threshold matter, we must address whether the “carve out” of Federal business is dispositive of the question of whether the Existing Arrangement implicates the anti-kickback statute, It is not. The OIG has a long-standing concern about arrangements pursuant to 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 business through the payment of amounts purportedly related to non-Federal business. Here, IDTFs participating in the Existing Arrangement may still influence referrals of Federal health care program beneficiaries to the Requestor for DME. Thus, we cannot conclude that there would be no nexus between the Requestor’s payments to the IDTF for services provided to non-Federal patients and referrals to the Requestor of Federally insured patients.

John H. Fisher

Health Care Counsel
Ruder Ware, L.L.S.C.
500 First Street, Suite 8000
P.O. Box 8050
Wausau, WI 54402-8050

Tel 715.845.4336
Fax 715.845.2718

Ruder Ware is a member of Meritas Law Firms Worldwide

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