The Office of Inspector General (“OIG”) of the Department of Health and Human Services, generally, would have concerns about a potential or existing referral source receiving free goods or services, since these free goods and services could be used to provide unlawful payments for the referral of Federal health care program business.  However, under Advisory Opinion 16-09, the OIG decided not to pursue sanctions against a company that provides computerized point-of-care storage and dispensing systems for vaccines (the “Dispensing System”) to physicians free of charge due to the specific circumstances in this arrangement.

The Arrangement:  A manufacturer of a refrigerated vaccine storage and dispensing system (the “Dispensing System”) would retain title to their Dispensing System and the internal data, but would provide the system free of charge to certain physicians.  The manufacturer would enter into two types of agreements:

1)  Sole-Source Vaccine Agreement – The Dispensing System manufacturer would enter into an agreement with manufacturers who are the sole suppliers of a vaccine (“Sole-Source Vaccine”).  The Sole-Source Vaccine manufacturer would pay the Dispensing System manufacturer a fee for each unit of vaccine that a participating physician dispenses out of the Dispensing System (the “Dispense Fee”).

2) Physician Agreement – Dispensing System manufacturer would enter into agreements with only those Physicians who had not previously stocked adult vaccines previously, or only stocked vaccines sporadically or in low volumes.  The Dispensing System would be free of charge to physicians, provided the physician agrees to stock at least one Sole-Source Vaccine that has an Agreement with the Sole-Source Vaccine manufacturer.  The physician would be responsible for the internet connectivity and utilities for the system.  The physician could use the Dispensing System to store other vaccines.  However, the physician may only store Sole-Source Vaccines if the vaccine manufacturer has an agreement with the Dispensing System manufacturer.

OIG’s Analysis: Due to the following “unique factors” the OIG concluded that the following arrangement would be permissible.

  • No Dispense Fee is shared with the physicians.
  • The Dispense Fee is paid directly to the Dispensing System manufacturer, who does not generate Federal healthcare program business.
  • The risk of unfair competition is reduced because (1) only Sole-Source Vaccine manufacturers can enter into an agreement with the Dispensing System manufacturer; (2) More than one Sole-Source Vaccine manufacturer can have their vaccines in any machine and each would be paying the Dispense Fee; and (4) Since a physician needs the Sole-Source Vaccine for patient, the physician has inherently chosen the manufacturer, since they cannot get the vaccine from anywhere else.
  • Physicians may store any non-sole-source vaccines in the Dispensing System that they wish.
  • The manufacturer will not advertise, market or promote any specific vaccine.
  • Adult vaccines are administered in limited manner and serve to prevent diseases, which if not prevented could lead to costlier services to federal payors.
  • The Arrangement helps achieve the CDC’s goal to improve adult vaccination rates which is a benefit from a public policy perspective.
  • The Dispensing System helps mitigate one of the key challenges – proper vaccine storage and management

While it appears the opinion is likely limited to the discrete issue of vaccine storage, it does demonstate that the OIG may be willing to entertain proposals that align with public health concerns or other government agency goals, even in situations where there could be a risk of fraud or abuse to federal payor programs.

If your practice is interested in guidance regarding free vaccine dispensing systems or similar arrangements, be sure to consult experienced counsel.

In a recent Advisory Opinion (No. 16-02), the OIG concluded that it would not seek sanctions against a state-run hospital (the “Hospital”) under the federal anti-kickback statute or the civil monetary penalty law for two arrangements under which the Hospital provides transportation aid and short-term lodging to pregnant women covered by federal health care programs.  Although the OIG stressed that the unique factors of the arrangements led to its decision, the OIG’s analysis offers some insight into its concerns regarding the provision of transportation and other aid to patients by a provider.

The Hospital is a state academic medical center that operates 11 Hospital-based clinics providing prenatal care (the “Clinics”).  The patients are primarily low-income women, and each is presented with the Hospital as a potential location for the delivery of her child.  In 2014, 97% of the Clinics’ patients who delivered at the Hospital had high-risk pregnancies.

Under the first arrangement, Hospital employees offer transportation aid to any Clinic patient with a high-risk pregnancy who expresses concern about the cost and distance of traveling to the Hospital for delivery.  The aid is offered in the form of mileage reimbursement or fare reimbursement (for public transportation).

Under the second arrangement, the Hospital offers a Clinic patient and her companions free lodging at an apartment building near the Hospital under certain circumstances.  The apartments have simple living accommodations and are staffed by an on-call nurse.  To be offered lodging, the patient must have a physician’s order justifying the stay.  As a result, the majority of the patients who receive free lodging under this arrangement have high-risk pregnancies requiring frequent monitoring.  Patients without high-risk pregnancies may be offered lodging only if they are experiencing contractions or are scheduled for induction of labor or delivery the following day.  All patients receiving free lodging also receive free transportation to the Hospital for delivery.

The Hospital stated that the purpose of the above-described arrangements is to allow Clinic patients to benefit from specialty and continuing care at the Hospital when close to the end of their pregnancies.  In its Advisory Opinion, the OIG acknowledged the Hospital’s legitimate purpose and concluded that it would not pursue sanctions against the Hospital under the federal anti-kickback statute or civil monetary penalties law, even though, in the OIG’s opinion, these arrangements implicated both laws.  The OIG emphasized that its decision was influenced by the unique circumstances of the arrangements, and that no individual factor (or any combination of factors other than all of them) would necessarily result in the same decision.  Nonetheless, the OIG’s concerns provide some insight into how the OIG would view similar arrangements in the future.

The OIG’s analysis rested on the following key factors of the arrangements:

  • The arrangements were beneficial to the patients because they provided continuity of care, access to specialty care, and focused on patients who lack sufficient financial means of delivering at the Hospital.
  • The aid given to the patients would be “modest” in nature and available only in limited circumstances.  Specifically, (i) the transportation aid would be available only if a patient expressed concern about her ability to afford the cost of traveling to the Hospital for delivery, and (ii) the lodging aid would be available only if the patient has a high-risk pregnancy or is scheduled for delivery the following day, and the patient receives a physician’s order justifying the stay.
  • The aid would not be advertised by the Hospital or the Clinics, and would be offered only to existing patients.  As a result, the OIG did not view this arrangement as being designed to serve as an inducement for patients to seek care at a Clinic or the Hospital over other providers.
  • Eligibility for the aid would not be limited to patients on the basis of their health insurance coverage.
  • The cost of the aid would not be claimed as bad debt or otherwise shifted to Medicare, Medicaid or another federal health care program.
  • The aid would be part of a program of care operated by a state-run academic medical center for the benefit of a large number of Medicaid and CHIP beneficiaries.  As a result, the OIG stated that it would expect the State to promote the integrity of the arrangements.

If you or your practice is interested in guidance on providing aid or other benefits to patients, be sure to consult experienced legal counsel.

The full text of the Advisory Opinion is available here:  http://oig.hhs.gov/fraud/docs/advisoryopinions/2016/AdvOpn16-02.pdf

Called by some the “King of Nursing Homes” for his many low-income nursing home patients in northeast Illinois, Dr. Venkateswara Kuchipudi was recently convicted for referring patients to Sacred Heart Hospital in Chicago in exchange for kickbacks.  Kuchipudi became the fifth physician and tenth defendant to be convicted for a massive Medicare and Medicaid fraud scheme that led to the closure of Sacred Heart Hospital.

Kuchipudi’s arrangement was not overly complicated.  He struck a deal with the Owner and CEO of Sacred Heart Hospital (who was recently sentenced to 4.5 years in prison) to refer all of his Medicare patients requiring hospital care to Sacred Heart in exchange for the Hospital’s assignment of an exclusive team of health care practitioners to treat Kuchipudi’s patients both inside and outside the Hospital.  In some instances, Kuchipudi referred patients to Sacred Heart for admission, despite the fact that other hospitals were closer in distance to the patients’ nursing homes and had better staffing and access to routine procedures, such as x-rays and lab work.

The arrangement allowed Sacred Heart Hospital to greatly increase its collections, netting the hospital owner upwards of $29 million over three years, while Kuchipudi was able to bill Medicare approximately $1.6 million for services provided by his exclusive team of Sacred Heart professionals.

Kuchipudi argued that his goal was to improve patient care and that he had no idea the arrangement could be construed as involving kickbacks for referrals.  The government countered by arguing that the anti-kickback statute is violated as long as at least one of the purposes of the arrangement is to induce referrals.  The jury sided with the government on 10 of the 12 charges.

Kuchipudi was convicted of one count of conspiracy to defraud the United States and nine counts of illegally soliciting or receiving benefits in return for referrals of patients covered under a federal health care program.  He was acquitted of two counts involving mileage reimbursements paid by the Hospital to one of the physician assistants assigned to treat Kuchipudi’s patients at nursing homes.

This case is another example of the federal government’s crackdown on fraud, waste and abuse in federal health care programs, and shows that violations of the federal anti-kickback statute can involve kickbacks in a form other than direct payment for referrals.  It underscores the need for physicians to carefully review their hospital and other provider relationships to be sure such arrangements do not – even inadvertently – run afoul of these complicated statutes.

The Affordable Care Act (ACA) requires Medicare providers to return overpayments within 60 days of the date they are identified in order to avoid liability under the False Claims Act.  Four years ago, CMS issued a proposed rule to implement this statutory requirement that would have placed a substantial burden on providers to identify and return overpayments within the 60-day period.  Last week, CMS issued its long-awaited “final rule” on the matter. The final rule is substantially less burdensome than the proposed rule would have been and offers providers a clearer view of their obligations to investigate and report overpayments.

Here are five key aspects of the final 60-Day Overpayment Rule that physicians and medical practices should keep in mind:

  1. What It Means to Identify an Overpayment

CMS clarifies that identifying an overpayment requires reasonable diligence and quantification of the overpayment.  Specifically, a provider has “identified” an overpayment when the provider “has or should have, through the exercise of reasonable diligence, determined that it has received an overpayment and can quantify the amount of the overpayment.”  In contrast, the proposed rule would have held providers to a “deliberate ignorance” or knowledge standard regarding the existence of an overpayment and would have included no leeway for quantification of the overpayment.

  1. The New Timeframe In Which Providers Must Identify Overpayments

One of the biggest questions that arose from the proposed rule was: “When does the 60-day clock to identify overpayments start ticking?”  The proposed rule called for providers to act with “all deliberate speed” to identify overpayments once they became aware of a possible billing error.  In its final rule, CMS provides a clearer answer to the question.  Providers will have up to 6 months to investigate a possible overpayment before the 60-day reporting period begins.

  1. The “Look-Back Period” Is Shortened

Part of a provider’s obligation with respect to overpayments under the ACA is to search through past records for overpayments after a provider identifies that it has received at least one overpayment.  CMS originally proposed a requirement that providers “look back” 10 years in their records for other overpayments in order to comply with this rule.  Acknowledging the unreasonable burden such a time period would impose on providers (both in effort and cost), in the final rule CMS has reduced the duration of the look-back period to 6 years.

  1. Documentation of Reasonable Diligence Is Advisable

In prefatory comments to the rule, CMS stated that it is “certainly advisable” for providers to document their diligence in investigating possible overpayments.  While documenting an investigation may not make a provider’s diligence “reasonable” per se, it may provide strong evidence of the provider’s efforts.

  1. Proactive Compliance

CMS emphasizes in the final rule that “reasonable diligence” requires not only reactive activities, such as a good faith investigation of potential overpayments by qualified individuals, but also “proactive compliance activities conducted in good faith by qualified individuals to monitor for the receipt of overpayments.”

The full text of the final rule may be accessed here:  https://www.federalregister.gov/articles/2016/02/12/2016-02789/medicare-program-reporting-and-returning-of-overpayments.

Be sure to consult experienced legal counsel if you would like further guidance on the Medicare 60-Day Overpayment Rule, including what steps your practice should take to proactively and reactively address potential overpayments.

You may have heard some years ago that the Affordable Care Act established a “60-day overpayment rule” that requires a provider to report and return any overpayment from a federal health care program (such as Medicare or Medicaid) within 60 days of “the date on which the overpayment was identified” by the provider (for certain institutional providers, the overpayment must be returned by the later of 60 days or the date on which a corresponding cost report is due to the applicable federal health care program).   Failure to return the overpayment within the required time period (60 days for physician practices) subjects the provider to liability under the False Claims Act and a fine of up to $11,000 per claim plus treble damages.

In an effort to clarify the rule, in 2012, CMS proposed that a provider has “identified” an overpayment when the provider has either “actual knowledge of the existence of the overpayment” or acted in “reckless disregard or deliberate ignorance of the overpayment”.  77 Fed. Reg. 9179, 9182-83.  However, CMS received so much negative feedback regarding its proposed interpretation of the rule that it decided to delay final guidance until 2016.  In the interim, the first court to review the 60-day overpayment rule has had an opportunity to give its opinion.

 

The Court’s Decision

In U.S. ex rel. Kane v. Continuum Health Partners, Inc., the U.S. Department of Justice, along with an ex-employee whistleblower, brought suit against Continuum Health Partners, Inc. on the grounds that Continuum failed to report and return over 900 Medicaid overpayments within 60 days of identification.   The government argued that Continuum “identified” the overpayments when the ex-employee (who was charged with investigating a software glitch in the billing system) emailed a spreadsheet of over 900 potential Medicaid overpayments to upper management of Continuum.   Continuum argued that it should not have been responsible to report or return the overpayments until it determined the precise amounts of the overpayments.

The Court sided with the federal government, denying Continuum’s motion to dismiss the case.  The Court held that Continuum “identified” the overpayments for purposes of the 60-day overpayment rule when Continuum was put on notice that the overpayments were likely to exist.  The Court explained that the spreadsheet provided by the whistleblower did not need to “conclusively establish each erroneous claim” and it did not need to “provide the specific amount owed” in order to put Continuum on notice of each overpayment, and thereby start the 60-day reporting clock.

 

What The Case Means for Providers

The Court’s decision in Continuum is not the last word on this issue.  The Court left open what it means to be “put on notice” that an overpayment is likely to exist.  Also, as noted, CMS may issue new guidance on the rule next year.  Nonetheless, the decision can provide useful guidance for providers who have discovered a potential overpayment and want to know how to comply with the rule.

The Court explained that a provider has a duty to investigate and report an overpayment within 60 days after the provider has been put on notice that the overpayment is likely to exist.  The Court also noted that a provider should not be liable under the False Claims Act for failing to return an overpayment within 60 days, if the provider (i) has reported the overpayment, (ii) is diligently investigating it, and (iii) does not intend to withhold repayment once the proper amount has been established.

In sum, the main message of the Court’s opinion is to Take Action and Report the Overpayment.  If you discover a potential overpayment, begin investigation in a reasonable timeframe.  If you are unable to determine whether the claim actually resulted in an overpayment within the 60-day time period, err on the side of caution by reporting and returning the potential overpayment.  If the overpayment(s) are substantial in amount, you may consider withholding repayment; however, be sure to report to CMS (or the applicable federal health program administrator) as much information regarding the claim as possible, including your intention to return each overpayment once the amount to be repaid is established.

Finally, before taking any action, be sure to consult your legal counsel regarding the best options for you and your practice.

Earlier this month the closely watched case of U.S. ex rel Drakeford v Tuomey Healthcare System Inc. (675 F.3d 394 (4th Cir. 2012) concluded with a jury finding that the compensation paid to physicians under certain part-time employment agreements by Tuomey Healthcare System resulted in violations of both the federal False Claims Act and the federal Stark law.

The Stark law prohibits a physician from referring to an entity for Stark "designated health services" (including outpatient and inpatient hospital services) if the physician has an ownership or compensation relationship with that entity.  While there is an exception to the Stark law prohibition for bona fide employment arrangements, one requirement of that exception is that the compensation paid must be consistent with fair market value.

Although Tuomey relied upon an expert assessment of the fair market value, the government’s expert disagreed and the jury obviously found the government’s case to be compelling.

Under the False Claims Act, Tuomey’s penalties could exceed $350 million. Although the Tuomey case is interesting for a number of reasons, perhaps the primary lesson to be learned is that a proper, defensible assessment of fair market value In hospital-physician arrangements–even W2 employment arrangements–is critical.
 

On March 26, 2013, the Office of Inspector General published much-awaited guidance on physician-owned medical device distributorships (commonly known as “PODs”) in the form of a Special Fraud Alert.  The OIG makes no bones about where it stands on PODs which it describes as “physician-owned entities that derive revenue from selling, or arranging for the sale of, implantable medical devices ordered by their physician-owners for use in procedures the physician-owners perform on their own patients at hospitals or ambulatory surgical centers.”

The Fraud Alert describes a number of characteristics which, according to the OIG, make POD arrangements potentially suspect under the federal anti-kickback statute.  These include the following:

1.            Selection of investors because they are in a position to generate substantial business for the entity.

2.            Requiring investors who cease practicing in the service area to divest their ownership interests.

3.            Distributing extraordinary returns on investment compared to the level of risk involved.

4.            Choice of brand and the type of device may be made or strongly influenced by the physician.

5.            The size of the investment offered to each physician varies with the expected or actual volume or value of devices used by the physician.

6.            Distributions are not made in proportion to ownership interest, or physician-owners pay different prices for their ownership interests, because of the expected or actual volume or value of devices used by the physicians.

7.            Physician-owners condition their referrals to hospitals or ASCs on their purchase of the POD’s devices through coercion or promises, for example, by stating or implying they will perform surgeries or refer patients elsewhere if a hospital or an ASC does not purchase devices from the POD, by promising or implying they will move surgeries to the hospital or ASC if it purchases devices from the POD, or by requiring a hospital or an ASC to enter into an exclusive purchase arrangement with the POD.

8.            Physician-owners are required, pressured, or actively encouraged to refer, recommend, or arrange for the purchase of the devices sold by the POD or, conversely, are threatened with, or experience, negative repercussions (e.g., decreased distributions, required divestiture) for failing to use the POD’s devices for their patients.

9.            The POD retains the right to repurchase a physician-owner’s interest for the physician’s failure or inability (through relocation, retirement, or otherwise) to refer, recommend, or arrange for the purchase of the POD’s devices.

10.          The POD is a shell entity that does not conduct appropriate product evaluations, maintain or manage sufficient inventory in its own facility, or employ or otherwise contract with personnel necessary for operations.

11.          The POD does not maintain continuous oversight of all distribution functions.

12.          When a hospital or an ASC requires physicians to disclose conflicts of interest, the POD’s physician-owners either fail to inform the hospital or ASC of, or actively conceal through misrepresentations, their ownership interest in the POD.

13.          POD exclusively serves its physician-owners’ patient base.

14.          Physician-owners are few in number, such that the volume or value of a particular physician-owner’s recommendations or referrals closely correlates to that physician-owner’s return on investment.

15.          Physician-owners alter their medical practice after or shortly before investing in the POD.

Although the OIG notes that not all PODs will necessarily be illegal under the statute, it believes they are “inherently suspect”.

In what would undoubtedly be a devastating blow to many medical practices that rely on the Stark in-office ancillary services exception (which allows physicians to refer within their practices for Stark services), President Obama’s proposed FY 2014 would seek to eliminate the exception for physical therapy, radiation therapy and advanced imaging such as CT and MRI.  The budget suggests that the exception may still apply for those providers that meet certain "accountability standards" established by the Secretary of the Department of Health and Human Services.  The proposed budget offers no further detail on what these accountability standards might be. 

Although passing budgets has not been much of a priority in Washington for the last few years, this proposal clearly demonstrates that these services in the physician office setting are targeted for extinction.  Practices that offer these services should begin making contingency plans now to divest or restructure in the event that the exception is eliminated.

Yesterday the U.S. Department of Justice announced that it has entered into a $26M False Claims settlement with a dermatologist in Florida.  According to the DOJ, this is one of the largest False Claims settlements against an individual in history.  The physician was accused of allegedly accepting kickbacks from a pathology lab and billing for medically unnecessary services. 

The Obama administration announced today that as a result of increased federal health care fraud and abuse enforcement efforts, the federal government recovered $4.2 billion in 2012, setting a new record.  According to the Department of Health and Human Services, for every $1 spent on enforcement efforts, they recouped $7.90.  For more on the topic see "U.S. recovers $4.2 billion from healthcare fraud probes: report" on reuters.com.