Overpayment Rule Sets 6 Year Lookback

Nearly 6 years after the passage of the Affordable Care Act, CMS published the final 60 day rule for Medicare Parts A and B overpayments. The rule requires a person who has received an overpayment to report and return the overpayment to HHS, the State, an intermediary, a carrier or a contractor within 60 days after the date the overpayment was identified or the due date of any corresponding cost report, as applicable. The final rule is codified at 42 CFR 401.301 – 305; 401.607. Failure to properly identify and return overpayments may lead to liability under the False Claims Act.

The Final Rule sets a 6 year lookback period and clarifies what it means to identify an Overpayment. Prior to publication of the Final Rule, CMS previously published final rules for Medicare Parts C and D. As we previously reported, the New York District Court considered the “identification issue” in Kane v. Healthfirst, Inc. Unlike the Final Rule, the Court in Kane did not allow for quantification of an overpayment prior to commencement of the 60 day clock.

A. Ten Year Lookback Burden ‘Reduced’ to Six Years.

As we described in a February 2012, blog post, CMS initially proposed a ten year lookback period. The final rule eases this burden and requires that an overpayment be reported and returned within six years of receipt of the overpayment. In CMS’s view, “[c]reating this limitation for how far back a provider or supplier must look when identifying an overpayment is necessary in order to avoid imposing unreasonable additional burden or cost on providers and suppliers. Yes, 6 years is better than 10, but CMS declined to adopt a 4 year lookback as contained in the current reopening rules at 42 CFR 405.980. In reaching the 6 year rule, it appears that CMS contemplated burden, statutes of limitation in enforcement statutes, and state law record retention rules that require providers to retain records for 6 or 7 years.

B. Clarification of Meaning of ‘Identification’ of An Overpayment.

When does the 60 day clock start? The ACA provides that an overpayment must be reported and returned by the later of (i) the date which is 60 days after the date on which the overpayment was identified; or (ii) the date any corresponding cost report is due, if applicable. The Final Rule clarifies that “a person has identified an overpayment when the person has, or should have through the exercise of reasonable diligence, determined that the person has received an overpayment and quantified the amount of the overpayment.” 81 Fed. Reg. 7654. Conversely, the Final Rule provides that “a person should have determined that the person received an overpayment and quantified the overpayment if the person fails to exercise reasonable diligence and the person in fact received an overpayment.” 81 Fed. Reg. 7661, 7683. Moreover, it identifies specific examples of where an overpayment may be identified. 81 Fed. Reg. 7659.

1. Reasonable Diligence in Quantifying an Overpayment – The commentary to the Final Rule provides guidance on what constitutes reasonable diligence. In terms of quantifying an overpayment, reasonable diligence is demonstrated “through the timely, good faith investigation of credible information, which is at most 6 months from receipt of the credible information, except in extraordinary circumstances.” Extraordinary circumstances are fact specific but may include unusually complex matters. Reasonable diligence in the Final Rule replaced the concept of “all deliberate speed” in the proposed rule.

2. Reasonable Diligence Through Compliance Activities – Under the Final Rule, reasonable diligence includes both proactive compliance activities conducted in good faith by qualified individuals to monitor for the receipt of overpayments and investigations conducted in good faith in a timely manner by qualified individuals in response to obtaining credible information of a potential overpayment. The Final Rule admonishes the provider and supplier community to engage in meaningful compliance activities:

We believe that undertaking no or minimal compliance activities to monitor the accuracy and appropriateness of a provider or supplier’s Medicare claims would expose a provider or supplier to liability under the identified standard articulated in this rule based on the failure to exercise reasonable diligence if the provider or supplier received an overpayment.

81 Fed. Reg. 7661.

C. Reporting.

A person will satisfy the reporting obligations by making a disclosure under the OIG’s Self-Disclosure Protocol or the CMS Voluntary Self-Referral Disclosure Protocol. Otherwise, providers are required to use “an applicable claims adjustment, credit balance, self-reported refund, or other reporting process set forth by the Medicare contractor to report an overpayment.” Those SRDPs submitted prior to the effective date of the Final Rule will still be governed by the 4-year lookback period. Going forward the 6-year look back period will apply, though CMS still needs to modify this period with the OMB with regard to the financial analysis they are allowed to collect under the Paperwork Reduction Act. Therefore, at this point providers may voluntarily provide information for the 5th and 6th year. 81 Fed. Reg. 7673.

D. Conclusion.

In light of the Final Rule, providers should evaluate their compliance and auditing activities and evaluate the extent to which they could demonstrate “reasonable diligence.” In general, providers should work diligently to quantify and report overpayments by no later than 8 months (6 months to quantify, 2 months to report).

Adam Snyder is Chair of the Ogden Murphy Wallace Business Department and is a Part-time/Adjunct Faculty member of the University of Washington School of Law. For additional information regarding the Medicare 60 Day Overpayment Rule, Corporate Compliance, or internal investigations, please contact Adam Snyder.

CMS Issues Stark Law Changes

CMS issued last week its final rule modifying the Physician Self-Referral Law aka the Stark Law putting into place most of what it proposed to modify this summer. The majority of the new modifications become effective on January 1, 2016, though CMS indicates that many of the changes are just clarifications of existing application of the Stark Law.

Highlights of Some Proposed Revisions

The below list is not an all-inclusive list of the revisions to the Stark Law, but highlights some of the more substantial changes.

Temporary Noncompliance with Signature. Following the confusion between what was considered inadvertent and not inadvertent, CMS has modified this rule to allow the temporary noncompliance with the signature requirements for up to 90 days following the date of noncompliance regardless of the parties’ intention for not signing earlier.

Remuneration. The definition of remuneration has been revised to more clearly specify that certain items, devices, or supplies related to the collection, transportation, etc. of specimens are excluded from the definition of remuneration if used solely for one or more of such testing/specimen collection purposes.

Arrangement vs. Agreement. CMS clarifies in several of the exceptions (i.e personal services, leases, physician recruitment, etc.) that the requirement that the arrangement be set out in writing does not require a single formal contract but rather that several documents may establish sufficient documentation to satisfy the writing requirements. Examples of supplementary contemporaneous documents may include communications between the parties, check requests or invoices, time sheets, and call coverage schedules. Further examples are described within the final rule.

Holdover Provision. Prior to this final rule, the personal service arrangement, rental of office space and rental of equipment exceptions permitted a holdover arrangement for up to 6 months. CMS has modified these provisions to permit indefinite holdovers, provided that the arrangement continues on the same terms and conditions as the original arrangement.

Recruitment of Non-Physician Practitioners. CMS has added a new exception allowing a hospital (FQHC and RHC) to provide remuneration to a physician to compensate for non-physician practitioners if certain conditions are met (including cap of 50% of remuneration paid to non-physician practitioner and restriction on using the exception with the same referring physician only once every 3 years). Such non-physician practitioners include clinical psychologists and social workers, physician assistants, nurse practitioners, clinical nurse specialists and certified nurse midwives.

Timeshare Arrangements. CMS created a new exception for timeshare lease arrangements, which includes both space and equipment (supplies, items, services, etc.). The space/equipment must be predominately used for E/M services and remain on the same schedule. The equipment in the space must also be located in the same building as where the E/M services are furnished, not used to furnish DHS other than those incidental to E/M services furnished at the time of the patient’s visit and not include advanced imaging equipment, radiation therapy equipment or clinical & pathology lab equipment (other than CLIA waived tests).

The changes that relax some of the signature, holdover and writing requirements are consistent with CMS’ experience with SRDP submissions. Further the new exceptions recognize some of the changes in the delivery of patient care (such as non-physician providers and timeshare arrangements).  If you have questions about any of these modifications or the Stark Law in general please contact Elana Zana.

 

 

 

WHOA ME! TUOMEY!

For the second time in the past three years, Tuomey Healthcare System found its fate in the hands of the 4th Circuit Court of Appeals as a Qui Tam Defendant under the False Claims Act (“FCA”). Only this time it did not fare quite as well in what amounts to a crushing defeat. Back in 2012, pending retrial on allegations that Tuomey violated the FCA, the 4th Circuit Court of Appeals vacated a $45 million judgment stemming from violations of the Stark Law, see prior article here.  Now, on July 2, 2015, the 4th Circuit affirmed the district court’s decision on retrial that Tuomey submitted 21,730 False Claims based on Stark Law violations and was thereby liable for $237,454,195 in damages and penalties. The 4th Circuit rejected Tuomey’s arguments that no reasonable jury could have concluded that Tuomey violated Stark or intended to submit False Claims and that it was entitled to a new trial based upon various assignments of error related to jury instructions and damages issues related to measurement and constitutional matters.

The result is stunning, and should give pause to health lawyers, consultants and healthcare executives who find themselves walking the tightrope between sound business judgment and the complicated maze of the Stark Law and other complex healthcare rules. Indeed, in his concurring opinion, Judge Wynn expressed distaste for the outcome:

But I write separately to emphasize the troubling picture this case paints: An impenetrably complex set of laws and regulations that will result in a likely death sentence for a community hospital in an already medically under-served area…..Health care providers are open to extensive liability, their financial security resting uneasily upon a combination of their attorneys’ wits [and] prosecutorial discretion.” [citations omitted]. Despite attempts to establish “bright line” rules,…the Stark law has proved challenging to understand and comply with.

This case is troubling. It seems as if, even for well-intentioned health care providers, the Stark Law has become a booby trap rigged with strict liability and potentially ruinous exposure – especially when coupled with the FCA.

Judge Wynn’s words were not lost on the majority:

Finally, we do not discount the concerns raised by our concurring colleague regarding the result in this case. But having found no cause to upset the jury’s verdict in this case and no constitutional error, it is for Congress to consider whether changes to the Stark Law’s reach are in order.

Short of congressional action, CMS recently announced Stark-related proposals [http://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2015-Fact-sheets-items/2015-07-08.html] that could ease the burden of the law. Tuomey will need to find its relief elsewhere.

Stark Generally.

A physician may not make a referral to an entity for the furnishing of designated healthcare services (“DHS”) if the physician has a financial relationship with the entity, unless an exception applies. DHS include inpatient and outpatient hospital services. A referral does not include any DHS personally performed or provided by the referring physician. There is a referral, however, when the hospital bills a facility fee in connection with personally performed services. A financial relationship may exist through ownership or a compensation arrangement.

Tuomey’s Reaction to Business Challenges.

Tuomey is a nonprofit community hospital in Sumter, South Carolina, a mostly rural, medically underserved area. In the early 2000s, like so many other community hospitals, Tuomey faced the challenge of dropping outpatient volumes due to physicians performing procedures in their own offices or in ambulatory surgery centers. Tuomey’s future looked bleak and tens of millions in lost revenue was predicted. Tuomey developed a strategy to enter into part-time employment agreements with several previously-independent physicians on its medical staff. The arrangements were problematic for several reasons, without considering their current $237 Million price tag:

 

  • Compensation that varied year to year based on collections;
  • A requirement that Physicians perform outpatient procedures at Tuomey facilities;
  • Productivity bonuses of eighty percent of collections and an additional incentive bonus up to 7 percent of the productivity bonus;
  • Physicians were paid more than their collections, despite fair market value opinions from valuation experts;
  • Tuomey provided malpractice coverage, and performed the billing;
  • Ten year terms with 2 year back-end non-competes;
  • Physician who refused the arrangement and raised specific Stark issues (e.g. the Qui Tam Plaintiff in this case, Dr. Drakeford); and
  • Competing expert legal opinions from top health lawyers who were kept in the dark from one another and rejection and lack of diligence regarding negative opinions from counsel

 

Following two trials and two appeals, the 4th Circuit affirmed the $237 Million jury verdict and concluded that the trial court correctly granted a motion for a new trial, and rejected Tuomey’s various claims of error. As discussed below, the Court considered and commented on several important Stark and FCA issues.

Significant Aspects of 4th Circuit’s Opinion

 

Testimony of Kevin McAnaney:

 

Following the first Tuomey trial in 2010, the jury found that Tuomey had violated the Stark Law, but not the FCA. The trial court granted a post-trial motion based on what it viewed as its substantial error in excluding the testimony of Tuomey’s Senior Vice President and Chief Operating Officer, Gregg Martin. The 4th Circuit agreed that a new trial was proper, but reached that decision on slightly different grounds – the trial court’s exclusion of Kevin McAnaney’s testimony. Mr. McAnaney, a lawyer in private practice, was retained by Dr. Drakeford and Tuomey to advise of the Stark Law risks. Mr. McAnaney previously wrote a substantial portion of the Stark Law regulations in his role as Chief of the Industry Guidance Branch of DHHS Office of General Counsel to the Inspector General. The Court and the jury, apparently, found the McAnaney testimony to be particularly probative of the knowledge element of the FCA. McAnaney advised that the Tuomey employment agreements raised significant “red flags” under the Stark Law, such as compensating physicians in excess of their collections, thus making the arrangement “an easy case to prosecute.”

 

On McAnaney’s testimony, the 4th Circuit observed and concluded the following:

 

In the first trial, the jury did not hear from McAnaney and found for Tuomey on the FCA claim. When the case was retried, McAnaney was allowed to testify and the jury found for the government. Coincidence? We think not.

Indeed, it is difficult to imagine any more probative and compelling evidence regarding Tuomey’s intent than the testimony of a lawyer hired by Tuomey, who was an undisputed subject matter expert on the intricacies of the Stark Law, and who warned Tuomey in graphic detail of the thin legal ice on which it was treading[.]

Jury Reasonably Found Stark Violations:

 

It is unremarkable in a general sense that the 4th Circuit refused to set aside a jury verdict and find that no reasonable jury could have concluded that Tuomey violated Stark. Tuomey argued, unsuccessfully, that the only question that should have gone to the jury was whether the contracts, on their face, took into account the value or volume of anticipated referrals. The Court concluded that two components of the physicians’ compensation varied with the volume or value of referrals. The physicians were paid a base salary that was adjusted upward or downward in the subsequent year depending on collections from the prior year. The physicians were also paid a productivity bonus that was set at eighty percent of their collections. The Court concluded that it was “plain that a reasonable jury could find that the physicians’ compensation varied with the volume or value of actual referrals.” The Court also recalled its earlier opinion where it noted that the tainted referrals were the “facility component of the physicians’ personally performed services, and the resulting facility fee billed by Tuomey based upon that component.”

False Claims Act

 

The Court rejected Tuomey’s claim that no reasonable jury could have found a violation of the FCA because it acted on the advice of counsel. The court again pointed to the testimony of attorney McAnaney and amplified the District Court’s conclusion that a “reasonable jury could have found that Tuomey possessed the requisite scienter once it determined to disregard McAnaney’s remarks.” Tuomey’s ‘advice of counsel’ defense ultimately failed because it was unable to show that there had been a full disclosure of all pertinent facts to and among legal counsel, and a lack of good faith reliance on just the favorable legal advice. The Court was not persuaded by Tuomey’s claims that it had, following Mr. McAnaney’s negative view, retained top national health lawyers from reputable firms to complete the transaction.

Tuomey Unsuccessfully Challenges Jury Instructions and Damages Award

 

The Court rejected Tuomey’s various claims of error related to jury instructions. Tuomey argued that the trial court failed to limit the jury’s inquiry to whether or not the contracts, on their face, took into account value or volume of anticipated referrals. The Court emphasized that the jury could consider the parties’ intent to determine if an arrangement took into account volume or value of referrals, but intent alone would not be enough to create a violation.

 

Tuomey argued that the jury should have been separately instructed on the knowledge element in the indirect compensation arrangement definition under Stark and in the FCA. The court found that any such error here was harmless since the jury’s conclusion that Tuomey possessed the requisite scienter under the FCA and also possessed knowledge that the Physicians’ aggregate compensation varied with referrals, a necessary element of the definition of an indirect compensation arrangement under Stark. 42 U.S.C. § 411.354 (c)(2)(iii).

 

Tuomey claimed that the trial court erred by failing to instruct the jury that disputed legal questions are not false claims under the FCA. As with all providers who bill Medicare, Tuomey was required to certify its compliance with laws, to include the Stark Law. Because the jury found that Tuomey violated the Stark Law, the certification of compliance was false, and therefore all tainted claims were false. This seems like fertile ground for further appellate challenge.

 

The Court rejected Tuomey’s challenge to the trial court’s failure to give an instruction that Tuomey was entitled to rely on legal advice even if it turned out to be wrong. The Court found that other jury instructions regarding knowledge under the FCA already were sufficient to cover Tuomey’s concern in this regard.

 

Finally, the Court rejected various challenges by Tuomey regarding the whopping $237,454,195 judgment. It argued that the trial court improperly calculated the penalty, that it incorrectly measured damages, and that the award violated the 5th and 8th Constitutional Amendments. The Court rejected all of Tuomey’s arguments, and found that the jury was properly instructed to consider all tainted hospital claims – both inpatient and outpatient, to determine prohibited referrals. The Court further concluded that the Government was allowed to rely on summary evidence of referrals, perhaps due in part to the fact that Tuomey did not offer its own expert as to damages calculations. The court rejected Tuomey’s challenge that the Government was not damaged, and rejected Tuomey’s claims that the award was unconstitutional under the Due Process Clcause of the 5th Amendment and the Excessive Fines Clause of the 8th Amendment.

 

The Court rejected Tuomey’s argument that if it submitted false claims that the only false claims were its annual cost report submissions and not the 21,730 UB-92/04 forms that it submitted. The Court concluded that Tuomey violated the FCA each time it submitted a claim for reimbursement because it was knowingly asking the government to pay an amount that, by law, it could not pay. Again, look for this issue to be prominently featured in a future appellate review of this case.

 

Takeaways from Tuomey

While Tuomey presents staggering results, it does represent a somewhat unusual set of facts. While it provides a strong reminder that hospitals should critically view their arrangements with referring physicians, it does not preclude the development of sound business and legal strategies within a complicated regulatory legal framework. The following are among the valuable lessons learned from Tuomey:

 

  • Courts and juries may look beyond the four corners of an agreement to determine if an arrangement takes account of volume or value;
  • Courts and juries may look beyond supporting items such as self-serving appraisals to find legal violations; Lawyers and their clients are best-advised to validate the assumptions supporting such appraisals;
  • There is a reason that nearly every FCA matter settles and that is due to the shear potential downside, as evidenced by this case;
  • Review arrangements with physicians and consider them and their fair market value support in the context of the history and intent that lead to the arrangements, to determine if they would pass Tuomey-like scrutiny;
  • Take care when bringing in the next lawyer to rule out a prior negative legal opinion or to break the tie between two competing legal opinions – who is the client? Where is the attorney-client privilege? How will all lawyers’ opinions be considered by the lawyers and the client?

 

Adam Snyder is Chair of the Ogden Murphy Wallace Business Department and is a Part-time/Adjunct Faculty member of the University of Washington School of Law. For additional information regarding Tuomey, Stark, or the False Claims Act, please contact Adam Snyder or Greg Montgomery.

 

Patient Engagement and Meaningful Use

I am very excited this week to present with my colleague Dave Schoolcraft at MGMA in Las Vegas.  We have two presentations on Tuesday, the first at 10:15 entitled the Legal Aspects of Meeting Patient Engagement, the second at 2:45 entitled Double Dipping for EHR Funding.

Vegas is all about the money, and Double Dipping for EHR Funding will focus on how physician practices can still obtain money for Electronic Health Record systems.  The presentation will focus on Stark/Anti-Kickback Donation Arrangements and Meaningful Use dollars.  If you are looking to upgrade to 2014 CEHRT this is a presentation you don’t want to miss. Prior to joining our presentation, I suggest reading two articles we published earlier in the year: Understanding Stark/Anti-Kickback Compliant EHR Donation Arrangements and Key Lessons Related to Stark Compliant EHR Donation Arrangements.

As for Legal Aspects of Meeting Patient Engagement – this presentation focuses both on HIPAA Compliance and Meaningful Use. Stage 2 Meaningful Use includes five patient engagement related objectives, and this time CMS means business.  Two of these five objectives include measures requiring that at least 5% of patients take an action.  These five measures makes the implementation and use of patient portals essential, as portals are a key means of communication with patients and is an appropriate mechanism for each of these Meaningful Use objectives.

The relevant patient engagement Meaningful Use objectives I am referring to here include:

I have added links to the CMS Eligible Professional Specification Sheets for Stage 2 above because I find them very helpful in deciphering what each of these measures require.  Meeting these requirements is not a walk in the park, and my clients have expressed difficulty getting patients to send secure messages or login to  a portal.  Often the CEHRT itself makes these tasks quite difficult.  Patient engagement is core to growing a practice, especially as patients begin to pay for their healthcare and start to demand physician interaction via e-mail and other technologies.

If you are interested in learning more about these patient engagement requirements in Meaningful Use stop on by our presentation, or contact me directly.

 

Key Lessons Related to Stark Compliant EHR Donation Arrangements

Is your entity thinking about engaging in a Stark/AKS Compliant EHR Donation Arrangement?  If so, check out this list of top 5 issues to consider as you are assessing your options and your health IT alignment strategy.

1.  An EHR donation arrangement is an effective way for hospitals to align with their physicians.

In the world of health information exchange, having the technological ability to seamlessly communicate with a hospital or referring physician is crucial to effective patient care.  It enables physicians and hospitals alike to efficiently obtain patient information and to exchange this information as needed to ensure quality patient care.

2.  There are specific rules – and significant consequences for breaking those rules.

Be careful not to run afoul of the Stark or Anti-Kickback rules.  Ensure that your contracts are compliant with both Stark and Anti-Kickback and that the arrangement is not designed at rewarding referring physicians.  

3.  What is the hospital taking on when it becomes an EHR vendor?  

What are the consequences for a physician practice if the local hospital is also its EHR vendor?  In many arrangements the hospital is the contracting party with the EHR software vendor (i.e. Epic, Cerner, etc.) and owns the relationship.  Physician groups will look to the hospital to obtain necessary service, updates, modules and when the system malfunctions.  The hospital should evaluate if it is able to take on this role.

4.  Physicians need to know what to expect as recipients of an EHR donation.

Often times the physician group is giving up its autonomy in choosing the EHR vendor, configuration or customization and must often defer to the hospital to make appropriate purchase, upgrade and service decisions.  In addition, even though the hospital may be picking up the majority of the costs (no more than 85%) the investment may still be expensive (and will likely exceed the meaningful use incentive dollars).  Items such as hardware, storage, and operating system software are excluded from the donation.    

5.  Before you align, be clear about who will get the “record collection” if things don’t turn out.

Before entering into a donation arrangement the parties should have a clear understanding of what happens if the relationship goes awry.  How will the records be divided, extracted, or migrated into a new system?  Will the physician group be able to maintain a relationship with the software vendor independently?  What are the ramifications of changing vendors and separating from the hospital EHR?

Special thanks to ECG’s Michelle Holmes and OMW attorney David Schoolcraft for composing this list based on their HIMSS14 presentation “Using Stark/Anti-Kickback to Support Hospital/Physician IT Alignment Strategies.

For more information on designing Stark/Anti-Kickback compliant donation arrangements please see the previous posts describing the exception requirements and the 2013 updates.  For assistance in creating a donation arrangement please contact Elana ZanaMichelle Holmes or David Schoolcraft.

 

Understanding Stark/Anti-Kickback Compliant EHR Donation Arrangements

In 2006 and extended in December 2013, CMS issued Stark and Anti-Kickback exceptions/safe harbors permitting EHR technology donation arrangements between hospitals (and other organizations) and physician groups.  This exception permitted hospitals to aid physician groups, who may be referral sources, in acquiring and implementing EHR and other health information technology.  Originally, hospitals had a seven-year window in which to engage in these donation arrangements, though in December 2013 CMS extended the donation arrangements for an additional 7 years through December 31, 2021.

The arrangement may include the non-monetary donation of “items or services in the form of software or information technology and training services.”  Key components of the exception/safe harbor include:

  • The donation is provided from an entity to a physician.
    • Change in 2013 rules, this entity cannot be a lab.
  • The software is interoperable
    • Change in  2013 rules, software is deemed interoperable if it has been certified as “certified EHR technology” as that term is used by the ONC for the meaningful use/EHR Incentive Program.
  • Donor cannot restrict or limit the use or interoperability of the technology with other eRx or EHR systems.
    • Change in 2013 rules, CMS interprets this rule more broadly by providing a non-exclusive list of the types of technologies that are included in this restriction: “health information technology applications, products, or services.”
  • Physician must pay at least 15% of the costs for the technology (which amount cannot be financed by the hospital).
  • Neither the physician nor the physician’s practice makes the receipt of the technology a condition of doing business with the donor.
  • Neither eligibility of the physician nor the amount or nature of the donation is determined in a manner that takes into account the volume or value of referrals or other business generated between the parties.
  • The donation is set forth in writing, signed by the parties, specifies the items to be provided, the donor’s costs and the physician’s contribution, and covers all EHR items and services to be provided by the donor.
  • The donor cannot have knowledge of or disregard the fact that the physician already possesses equivalent items or services.
  • The donor cannot restrict or limit the physician’s right to use the software for any patient.
  • The donation cannot include staffing of physician offices and cannot be used to primarily conduct personal business or business unrelated to the physician’s medical practice.
    • Note the donation may also include other “software and functionality directly related to the care and treatment of individual patients (for example, patient administration, scheduling functions, billing, clinical support software, etc.” (71 FR 45152).
  • The donation arrangement does not violate the Anti-Kickback statute.
  • The exception expires December 31, 2021.

Beyond crafting a donation arrangement that satisfies both the Stark law exception and Anti-Kickback safe harbor, hospitals and physicians should assess overall technology alignment strategies and the goals and framework for such donation arrangements.  Making sure that clear expectations are set in advance, including understanding implementation, roll out and support, data ownership and extraction, and utilizing the EHR technology for government incentive programs, such as meaningful use, are important topics that should be addressed by the arrangement.

For those interested in learning more about this topic and are currently attending HIMSS14, David Schoolcraft, attorney at Ogden Murphy Wallace, and Michelle Holmes, principal at ECG Management Consultants, are presenting on Wednesday at 10 AM on Using Stark/Anti-Kickback To Support Hospital/Physician IT Alignment Strategies.  For further information about designing a compliant arrangement please contact Elana Zana or Dave Schoolcraft.

 

Stark Law Donation Exception Extended to 2021

Beating the deadline by mere days, CMS and the OIG released their final rules related to the Stark Law exception/Anti-Kickback safe harbor for EHR donation arrangements.  The new rules extend the donation arrangement exception until December 31, 2021.

The new rules become effective 90 days after publication, with the exception of the extension, which is effective on December 31, 2013.  These new rules permit existing donation arrangements to continue to operate beyond December 31, 2013, provided they remain in compliance with the Stark exception and Anti-Kickback safe harbor.

Highlights of this new rule (other than the very important extension to 2021) include:

  • The items/EHR are provided by a company (i.e. a hospital) that is not a laboratory.
  • Software is deemed interoperable if it has been certified as “certified EHR technology” as that term is used by the ONC for the meaningful use/EHR Incentive Program.
  • Elimination of the requirement that the EHR software contain eRx capabilities in order to qualify for the exception.
  • Clarification that the donor cannot limit the interoperability of the donated software with other eRx and EHR systems, which CMS interprets more broadly by providing a non-exclusive list of the types of technologies that are included in this restriction: “health information technology applications, products, or services.”

For more information about drafting donation arrangements or these final rules please contact Elana Zana or Dave Schoolcraft.

To view the HIMSS statement on the extension click here.

SRDP Settlement: Improper EHR Donation Arrangement Among Violations

Last month CMS settled several violations of the self-referral statute (aka Stark Law) with an Ohio hospital, including a failure to appropriately structure a donation arrangement for electronic health records (EHR) .  The hospital disclosed under the Self-Referral Disclosure Protocol that it may have violated the Stark Law with regard to several arrangements with certain physicians, including arrangements for EKG interpretations, medical director services, Vice-Chief of Staff services, and hospital services (no specifics provided in CMS release).  The settlement was for $265,565.  The SRDP, which was included in the ACA, was created as a mechanism for providers to self-report potential Stark law violations.

The EHR donation arrangement to the Stark and Anti-Kickback laws permits hospitals to enter into certain arrangements with physicians for the donation of EHR related software and services.  The donation arrangement exception is scheduled to expire on December 31, 2013, however CMS has proposed extending the exception through 2016.  If CMS does not extend the exception, existing donation arrangements will have to convert to fair market value for shared technology and services.

If you have questions regarding the SRDP or structuring a EHR donation arrangement please contact Elana Zana.

Urology Group Challenge to Stark Regulations Is Too Little Too Late

A recent federal district court decision granted summary judgment to the government in a lawsuit by a urology group challenging the 2008 changes in Stark regulations affecting “under arrangement” services for hospital patients.  The decision illustrates the significant barriers to a successful challenge to these regulations.

The challenge focused on the 2008 regulatory changes that swept entities performing DHS into the definition of entities “furnishing” DHS and reversed CMS’ 2001 regulatory approval of “per click” lease agreements.  Several challenges to these changes were dismissed for not being raised within the six year limitation period applicable under the federal Administrative Procedures Act.

The arguments against these changes that survived the timeliness bar failed to convince the court that the changes were contrary to express Congressional intent stated in the legislation or were an impermissible interpretation of the legislation.  The court rejected an argument that the group practice exception for certain compensation arrangements constituted a Congressional expression of intent that the term “entity” was not intended to include entities that furnished DHS.  The court readily concluded that including entities that performed DHS within the definition of entities “furnishing” DHS was a permissible interpretation of the legislation.

As for the revision in the regulations to prohibit the previously permitted “per click” lease arrangements, the court noted that CMS is entitled to change its mind as long as there is a reasonable basis for the change.

“Thus, the agency remains free to reinterpret a statute in a way that varies greatly from its past interpretations so long as the agency provides a reasoned basis for its new interpretation.”

For more information regarding the Stark law or False Claims Act in general please contact Greg Montgomery.

 

Stark Law Really Does Have Teeth

Tuomey Jury Finds Monetary Value of $39 Million for 21,370 Claims Submitted in Violation of False Claims Act

On May 8, 2013, the jury in the False Claims Act lawsuit against Tuomey Healthcare Systems, Inc. returned its verdict.  Based on its finding that Tuomey violated the Stark law, the jury found that Tuomey also violated the False Claims Act by submitting 21,370 false claims with a total value in excess of $39 million.

The court instructed the jury that the government’s case was based on allegations that Tuomey entered into compensation arrangements with certain physicians that violated the Stark law.  The government sought relief under the False Claims Act for these alleged Stark law violations.

The court instructed the jury that damages for Stark based violations of the False Claims Act are to be based on what the Medicare program paid to Tuomey for claims submitted in violation of Stark.  Under the False Claims Act, each false claim is subject to a penalty of between $5,500 and $11,000.  In addition, damages may be tripled.

In what might be considered by some as a substantial understatement, one of the attorneys for Dr. Michael Drakeford, who initiated the lawsuit under the whistleblower provisions of the False Claims Act, was quoted as commenting:

“Perhaps the message to be taken from this verdict is that the Stark law really does have teeth and when a hospital decides to pay physicians for referrals, it risks paying a very high price.”

As part of its on-going quarterly lunch time webinar series, the Ogden Murphy Wallace Healthcare Practice Group will provide a presentation on self-disclosure options and avoidance of state and federal False Claims Act liability in its June 4, 2013 webinar (to register click here).  If you have questions regarding self-disclosure or Stark in general please contact Greg Montgomery.