Key Lessons Related to Stark Compliant EHR Donation Arrangements

February 26, 2014 By

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 Zana, Michelle Holmes or David Schoolcraft.

 

Filed Under: Anti-Kickback/Stark, Compliance, EHR, Health Information Technology, Stark Tagged With: , ,

Understanding Stark/Anti-Kickback Compliant EHR Donation Arrangements

February 25, 2014 By

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.

 

Filed Under: Anti-Kickback/Stark, Compliance, EHR, Hospitals, OIG, Stark Tagged With: , ,

Stark Law Donation Exception Extended to 2021

December 23, 2013 By

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.

Filed Under: EHR, OIG, Stark Tagged With: , , ,

SRDP Settlement: Improper EHR Donation Arrangement Among Violations

August 8, 2013 By

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.

Filed Under: Anti-Kickback/Stark, EHR, Hospitals, SRDP Tagged With: , ,

Urology Group Challenge to Stark Regulations Is Too Little Too Late

June 10, 2013 By

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.

 

Filed Under: Anti-Kickback/Stark, Compliance, False Claims Act, Medicare, OIG, Stark Tagged With: , ,

Stark Law Really Does Have Teeth

May 9, 2013 By

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.

 

Filed Under: Compliance, False Claims Act, Medicare, Stark

False Claims Act Recoveries Top $14.2 Billion

May 2, 2013 By

On May 1, 2013, the  Department of Justice announced a settlement with two Montana hospitals that added $3.95 million to its recoveries under the False Claims Act.  According to the announcement, with this additional recovery,  the Department of Justice has used the False Claims Act to recover more than $14.2 billion in federal healthcare payments since January, 2009.

Once again, allegations of hospital-physician financial relationships that violated the Stark law prohibition against self-referral were the stated basis for the allegations of False Claims Act liability.  In this case, according to the announcement, it was alleged that the hospitals paid incentive compensation to certain physicians in a manner that took into consideration the value or volume of the referrals by the physicians to the hospital by improperly including certain designated health services in the formula for calculating physician incentive compensation.

This situation was voluntarily disclosed by the hospitals.  In this regard, an OIG representative was quoted as commenting:

 “There is an expectation that corporations providing services to Medicare and Medicaid beneficiaries adhere to the provisions of the Stark Law.  I applaud St. Vincent Healthcare and Holy Rosary Healthcare for recognizing their potential liability in this matter and making a disclosure”

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 and overpayments in general please contact Greg Montgomery.

Filed Under: Anti-Kickback/Stark, Compliance, False Claims Act, Hospitals, Medicare, Overpayment, Stark

OIG Issues Updated Self-Disclosure Protocol

April 17, 2013 By

The OIG recently issued an update to its self-disclosure protocols to supply providers with additional guidance for self-disclosure.  In touting the benefits of self-disclosure, the OIG update notes that it now rarely requires integrity agreements in conjunction with self-disclosure settlement, it’s damage multiplier may be as low as 1.5, and the self-disclosure may stop the sixty (60) day clock running on potential False Claims Act liability.

The updated protocols emphasize that not every billing error is eligible for or should be reported under these protocols.  Reporting is limited to matters that may potentially violate federal laws for which civil monetary penalties are authorized.  Thus, for example, if you should discover that you may not have met all the criteria for provider based billing in an off campus clinic, you may have billing errors, but properly and promptly addressed, these do not invoke civil monetary penalties.

Recognizing that conduct for which civil monetary penalties are authorized also may be conduct that violates the Stark law, the updated protocols have a separate section providing guidance for disclosing arrangements that potentially violate both anti- kickback and Stark laws.  Arrangements that potentially violate both anti-kickback and Stark laws should be disclosed under the OIG protocol and not under the CMS stark self-disclosure protocol.  Of note in comparison to the CMS self-disclosure protocol for potential Stark violations, the updated OIG protocol is very clear that the self-disclosure submittal  must clearly acknowledge that the disclosed arrangement constitutes a potential violation of the anti-kickback and Stark laws.

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 2013 webinar (to register click here).  If you have questions regarding these updated protocols or self-disclosure and overpayments in general please contact Greg Montgomery.

 

Filed Under: Compliance, OIG, SRDP, Stark

Proposal Would Extend EHR Donation Rules

April 10, 2013 By

The U.S. Department of Health and Human Services (HHS) has released proposed rules to amend the electronic health record (EHR) donation exception and safe harbor under the Stark Law and Anti-Kickback Statute.  The exception and safe harbor permit certain entities to share costs associated with EHR-related items and services with other entities.   Under the regulations, the receiving party must pay at least 15 percent of the donor’s cost for the items and services.

The current language of the regulations has a “sunset” provision that requires a donor to transfer EHR items and services on or before December 31, 2013.  Under the proposed rules, HHS would extend the sunset provision three years to December 31, 2016.

Without the rule change, existing donation arrangements would have to convert to a “fair market value” model for shared services and technology.  The existing sunset provisions also provide a significant barrier to the development of new arrangements. 

The rules also include the following proposed revisions to the regulations: (1) changes to the requirements for when EHR software is deemed “interoperable, (2) removal of the requirement related to electronic prescribing capability, and (3) limits on the types of entities that are allowed to make EHR donations.

HHS also seeks suggestions on how to achieve the following goals under the exception and safe harbor: (1) preventing the misuse of donated EHR technology in a way that results in data and referral lock-in, and (2) encouraging the free exchange of data created by donated software.

You can view the proposed rule for the Anti-Kickback Statute here and the proposed rule for the Stark Law here.

HHS will accept comments to the proposed rules until June 10, 2013.

If you have any questions about donating EHR technology under the Anti-Kickback Statute and Stark Law, please contact David Schoolcraft or Casey Moriarty.

Filed Under: Anti-Kickback/Stark, EHR, Health Information Technology, Stark Tagged With: , , ,

OIG Releases 2013 Work Plan – Important Topics for Both Hospitals and Physicians

October 3, 2012 By

Fall must be here because the FY 2013 OIG Work Plan is out.  Providers of all shapes and sizes should at least browse the table of contents to see whether any of the  OIG’s topics for FY 2013 touch important aspects of their businesses and practices.  Among the many topics, some highlights include:

 

  • Analyze the “savings” of expanding the hospital three day payment window to 14 days;
  • Review Medicare payments for hospital discharges that should have been billed as transfers;
  • Review payment for canceled hospital surgical procedures;
  • Review effect on costs of hospital acquisition of ASCs;
  • Review payments for outpatient physical therapy services provided by independent therapists;
  • Review appropriateness of payments for sleep study services and the high utilization of sleep testing procedures;
  • Review coding of anesthesia services (personally performed versus medical direction of up to four concurrent procedures);
  • Review the payment for practice expenses of imaging services;
  • Review the medical necessity of high cost diagnostic imaging tests;
  • Review physician billing for “incident-to” services; and
  • Review physician coding of place of service.

 

Also of note, OIG states that it expects to publish a revised Provider Self-Disclosure Protocol some time in FY 2013.

If you have questions about any of these topics or the OIG Work Plan in general please contact Don Black.

 

Filed Under: Medicare, OIG, Stark
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