Hospital Pays $4.5 Million to Resolve False Claims Allegations

On August 25, 2009, the Department of Justice announced Covenant Medical Center in Waterloo, Iowa agreed to pay the United States $4.5 million to resolve allegations that it violated the False Claims Act. The settlement resolves allegations that Covenant submitted false claims to Medicare by having financial relationships with five physicians that violated the Stark Law. The government alleged that Covenant violated the Stark Law by paying commercially unreasonable compensation, far above market value, to five employed physicians. According to the government, these physicians were among the highest paid hospital-employed physicians not just in Iowa, but in the entire United States.

Covenant issued a press release denying any wrongdoing or illegal conduct. Covenant maintained the physician compensation was consistent with the approved compensation plan, was based on work personally performed by the physicians, and reflected their exceptionally high level or productivity. Covenant said it made a business decision to settle to avoid the uncertainty of litigation, disruption, and high expense associated with protracted litigation with the government. 

 

An article in the Des Moines Register on May 26, 2005 provides some information about the compensation. The paper reported that Covenant paid one orthopedic surgeon more than $2.1 million and a second orthopedic surgeon more than $1 million. A gastroenterologist was paid nearly $2.1 million. These figures were for the budget year ending in June 2003. 

 

DOJ's press release is here www.justice.gov/opa/pr/2009/August/09-civ-849.html

Kosenske: A Valuable Lesson for Group Practices

The U.S. Court of Appeals for the Third Circuit recently reversed summary judgment granted by the U.S. District Court for the Middle District of Pennsylvania in favor of a hospital and its anesthesia providers who asserted protection under the "personal services" exemption to Federal Stark Law ("Stark") and the Federal Anti-Kickback Statute ("AKS"). United States ex rel. Kosenske v. Carlisle HMA, Inc., No. 07-4616 (3rd Cir. 2009). 

The Plaintiff in the Qui Tam action was a member of the anesthesiology group, Blue Mountain Anesthesia Associates, PC ("the Group") which entered into a written contract with Carlisle Hospital and Health Services ("CHHS") for the exclusive right to provide anesthesiology services at the hospital. Pursuant to this exclusive service arrangement, CHHS agreed to provide office space, supplies, equipment and personnel for the Group's use at no charge when the Group was providing anesthesiology services to patients at the hospital. The contract contemplated that the Group would administer pain management services in addition to its more traditional anesthesia-related responsibilities, although, importantly, no pain management services were being provided when the contract was executed in 1992.

 

In 1998, CHHS built a new stand-alone facility containing an outpatient ambulatory surgery center and a pain clinic, located about three miles from the hospital. From the day of its opening, the Group provided pain management services to patients in the pain clinic and, in exchange, was given rent-free space and equipment in the pain clinic and support personnel at no charge. As with the anesthesia services, the Group's member physicians submitted claims to Medicare for the professional services performed during these visits, and CHHS submitted claims for the facility and technical component of the visits. The parties did not amend the 1992 agreement to include this additional facility or new range of responsibility. 

 

CHHS sold the hospital, surgery center, and other assets to Carlisle HMA ("Carlisle") in 2001. In furtherance of the sale, Carlisle and the Group conducted the business relationship as if the agreement with CHHS remained in effect. Both entities continued to submit claims to Medicare for their respective costs.

 

Plaintiff discontinued his practice with the Group and filed suit in 2005 alleging that Carlisle was noncompliant with Stark and the AKS, even though when submitting its claims for facilities costs to Medicare it had certified that it was in compliance. The Third Circuit agreed, making several important holdings:

 

(1)   The office space, medical equipment and personnel provided by Carlisle to the Group at no charge constituted remuneration in-kind and evidenced a financial relationship arrangement under the Stark Law;

 

(2)   No written agreement set forth the pain management relationship because the pain clinic was substantively different from inpatient anesthesia services addressed by the 1992 contract; and

 

(3)   Even if the 1992 contract was construed to apply to the pain management relationship, the agreement did not contemplate the provision of free office space, equipment and staff provided at the pain center. Therefore, the 1992 agreement did not specify the compensation to be paid over the term of the arrangement, as required by the personal services exception.

 

The Court acknowledged that, although arrangements between anesthesiologists and hospitals typically do not raise Stark or AKS concerns because anesthesiologists do not refer patients to the hospital, physicians seeing patients in a pain management clinic may refer patients to the hospital for tests or other procedures. After the Group expanded into providing pain management services, its members developed their own clientele capable of being referred to the hospital; thus, the Group was no longer a simple efficiency, but a referral source with a compensation relationship with the hospital. 

 

Kosenske serves as a reminder of the importance of adequately documenting all relationships between hospitals and physicians and the need to keep such documentation current. This case also highlights that supplying space, equipment and personnel by a hospital to its hospital-based service provider is not per se illegal; rather, the value of the space, equipment and personnel must be factored into an analysis of whether the overall arrangement is consistent with fair market value.

Gainsharing Programs Continue to Receive Favorable Reviews from OIG

Extending its string of positive advisory opinions involving gainsharing arrangements, over the past few months the OIG has issued three new, favorable gainsharing opinions. While the three gainsharing arrangements reviewed by the OIG in the recent opinions bear striking similarities to gainsharing arrangements that received favorable treatment in the past, there are some differences that suggest a broadening of the type of gainsharing arrangements that will receive OIG approval.

For instance, OIG Advisory Opinion 08-09 involves the first gainsharing arrangement that did not involve a hospital cardiology program. Rather, this opinion involved sharing savings from waste and cost reduction measures in certain surgical procedures with orthopedic surgeons and neurosurgeons. 

OIG Advisory Opinion 08-15 addresses a gainsharing arrangement involving cardiologists that has a term of three years. Previously, all gainsharing arrangements approved by the OIG were limited to one-year deals. By structuring the annual payments in a manner that ensured the participating cardiologists were not compensated twice for achieving duplicate savings, the OIG was receptive to approving a multi-year arrangement. This development is significant because a considerable downside to gainsharing arrangements had been the perceived one-year limitation. The 3 year term here is consistent with the maximum term proposed by CMS in the proposed Stark Law gainsharing exception.

Finally, OIG Advisory Opinion 08-16 is the first gainsharing arrangement to involve a commercial insurer and corresponding pay-for-performance initiatives. The hospital and commercial insurer developed a pay-for-performance program under which the insurer pays the hospital bonus compensation if the hospital meets specified quality and effeciency standards. The hospital entered into an agreement with a group of physicians to assist in meeting those standards and, if met, the hospital shares a portion of the bonus compensation from the insurer with the physicians. The program analyzed in this opinion represents an expansion of the type of quality-promoting arrangements the OIG is willing to accept.

Despite their unique characteristics, the arrangements in these opinions still incorporated key safeguards the OIG views as critical to protecting against potential fraud and abuse. Such safeguards include:

§            Transparency. The specific cost-saving actions and resulting savings are clearly and separately identified. The hospitals and participating physicians disclose the arrangement to patients.

§           No Adverse Impact on Patient Care. The parties provided credible medical support for the position that implementation of the cost-saving recommendations does not adversely affect patient care.

§           No Disproportionate Impact on Medicare Patients or Medicare Program. Amounts paid under the arrangement are based on all procedures regardless of a patient's insurance coverage and a disproportionate amount of such procedures are not performed on Medicare patients. If a participating physician's volume of procedures performed on Medicare patients in the current year exceeds the volume of like procedures performed on Medicare patients in the base year, there is no sharing of cost savings for the additional procedures.

§           Protections Against Inappropriate Reductions in Services. The arrangement utilizes objective historical and clinical measures to establish baseline thresholds beyond which no savings accrue to the participating physicians.  

§           Product Standardization Without Limiting Selection. Participating physicians still have available the same selection of devices and supplies after implementation of the arrangement as before. The arrangement is designed to produce savings through inherent clinical and fiscal value, not from restricting the availability of devices and supplies.

§           Compensation Cap and Per Capita Distribution. A cap on total compensation to the participating physicians is established based on projected cost savings and the compensation is distributed by the participating physician groups to their members on a per capita basis.

§           Participation Limited to Physicians on Staff. Participation in the arrangement is limited to physicians already on the hospitals' medical staffs. Also, the arrangement is limited to specific specialties (i.e. cardiology, orthopedics), so no surgeons or other physicians who refer patients to the participating physician groups can be rewarded through the arrangement.

§           Minimizing Incentive to Steer Costly Patients to Other Hospitals. Case severity, ages and payors of the patient population treated under the arrangement are monitored by a committee of hospital personnel and participating physicians. If significant changes from historical measures indicate a physician has altered his/her referral patterns to steer sicker, costlier patients away from the hospital, the physician can be terminated from the arrangement.

When structured appropriately to limit risk under the Anti-Kickback Statute and the Civil Monetary Penalties Law, the OIG has continually recognized the positive attributes of gainsharing programs. Gainsharing continues to be an evolving area with regard to fraud and abuse law and further developments are anticipated. CMS has issued requests for comments on several questions related to its proposed gainsharing exception to the Stark Law and it will be interesting to see how those questions and comments influence the development of the proposed exception.

CMS Issues Advisory Opinion on Stark Rural Provider Exception

CMS issued an advisory opinion concluding, based on the facts certified, that physician owners of a diagnostic center located in a micropolitan statistical area may refer patients to the center for designated health services (DHS) without violating the Federal physician self-referral (Stark) regulations because the arrangement would satisfy the "rural provider" exception.  The rural provider exception, which applies only to ownership or investment interests in DHS entities, requires that (a) the DHS is furnished in a rural area; and (b) substantially all of the DHS furnished by the entity (not less than 75%) must be furnished to residents of a rural area.  "Rural area" means an area that is not an urban area.  "Urban area" is defined at 42 C.F.R. 412.62(f)(1)(ii) to include Metropolitan Statistical Areas and New England County Metropolitan Areas (as defined by the Office of Management Budget) or certain specified New England counties.