Wednesday, March 1, 2017

Could Retrospective Chart Reviews Constitute a False Certification for MAO Data?

Image result for person asking a question


Kameron Gifford, CPC 

For those who live in the world of risk adjustment there has been a great debate among industry leaders in regards to the use of blind coding in retrospective audits. For those unfamiliar with the term, “blind coding,” it refers to coding and auditing medical records without access to the original claims data. These audits are typically performed by coding vendors hired by health plans to look for “missed” diagnosis codes.

Since, first posing the question, “Could retrospective chart reviews be considered Medicare Fraud?” in a June 2013 blog post, I have been an outspoken opponent of retrospective practices and have worked to promote prospective practices and frontline education.  

Whether you agree or disagree with my views, everyone in risk adjustment should be paying very close attention to the upcoming trial set for July 24, 2017 in the Graves vs Plaza Medical Centers case.

In her 5th Amended complaint, Dr. Olivia Graves claims that Dr. Cavanaugh and PMC intentionally submitted erroneous diagnoses codes on Medicare Advantage patients for the sole purpose of increasing their MRA scores and subsequently increasing their capitation payments.

Dr. Graves also contends that Humana “turned a blind eye” to the fraud and did nothing to correct the problem after repeated internal audits showed high error rates. She further contends that none of their “risk adjustment data validation” processes were designed to detect fraud, but instead to capture additional codes for the sole purpose of increasing capitation payments.

On January 17th the court denied summary judgement and found material issues of fact relating to compliance activities, certification of risk adjustment data and the retention of overpayments.

Key Points from the Court’s Report and Recommendation

§  The undersigned finds that evidence in the record that raises genuine issues of material fact as to whether the shortcomings of the design and application of Humana’s compliance program met the CMS regulations or constituted reckless disregard.

§  The relator argues that “ample evidence supporting scienter falls into two primary categories: (1) Humana’s failure to make ‘good faith efforts’ to certify the accuracy of its data submissions and maintain an ‘effective compliance program’ as required by law; and (2) the red flags that Humana ignored at the time and continues to ignore in its Motion.”

§  The relator argues that neither of Humana’s two forms of oversight related to the submission of risk adjustment data—the Medicare Risk Adjustment (“MRA”) Review and Provider Data Validation (“PDV”) Review—were designed to detect fraud or upcoding, and were therefore incapable of satisfying Humana’s obligations to make “good faith efforts” to certify the accuracy of the data to which it was attesting and maintain an “effective compliance program.”

§  The relator argues that Humana’s MRA Reviews did not detect International Classification of Diseases 9 codes (“ICD9 codes”) that were unsupported or likely to be unsupported by the medical record, but instead were designed to identify diagnostic codes for submission to CMS that providers may have overlooked.

§  The relator argues further that such one-way reviews are compelling evidence from which a reasonable jury could conclude that Humana did not make “good faith efforts” to certify the accuracy of its risk adjustment data and did not have an “effective compliance system.”

§  The relator offers evidence that the MRA Review was designed to identify diagnostic codes for submission to CMS that providers may have overlooked. Using algorithms to identify specific patients with potentially unreported conditions, the relator argues that the goal of Humana’s MRA reviews was to increase the capitated payment received by Humana and its providers

§  Rather than reviewing a patient’s lab tests, specialist reports, and underlying medical records, Humana’s PDV reviewers relied solely on a physician’s progress notes to confirm diagnosis; for chronic conditions, they validated the condition so long as its corresponding ICD-9 code appeared in the progress notes, even if those notes did not identify any confirming evidence or treatment plans for the diagnosed condition.

§  The evidence in the record raises genuine issues of material fact as to whether the false submissions that Humana made to CMS based on Plaza Medical Centers and Dr. Cavanaugh constituted reckless disregard under the FCA.

§  Humana contends that “effective” and “good faith” are ambiguous terms and that the relator fails to cite any CMS guidance regarding their definitions let alone warn Humana away from its interpretation of the governing regulations.

§  The relator relies on the CMS regulations found in 42 C.F.R. § 422.504(l)(2) and 42 C.F.R. § 422.503(b)(4)(vi)) that respectively require an MAO like Humana 1) make good faith efforts to certify the accuracy of its data submissions, and 2) maintain an effective compliance program.  Additionally, the relator relies on the Ninth Circuit’s Swoben decision that rejected the defendant’s arguments that the CMS regulations were ambiguous and that the defendant’s interpretation was objectively reasonable due to CMS’ clear, authoritative guidance that requires MAOs “to undertake ‘due diligence’ to ensure the accuracy, completeness and truthfulness of encounter data submitted to CMS.” Swoben, 832 F.3d at 1099 (citing Fidelity Fed. Sav. & Loan Ass’n v. de la Cuesta, 458 U.S. 141, 158 (1982)) “[A]mbiguity alone [does] not shield claimants from FCA liability.” 

§  CMS regulations obligated Humana to exercise “due diligence” and “good faith efforts” to certify the accuracy, completeness, and truthfulness of encounter data that Humana submitted to CMS.  The CMS requires that MAOs must implement a compliance program that detects and prevents fraud, waste and abuse.  The relator’s evidence presents a fact question as to whether Humana satisfied its CMS obligations or not which goes to the issue of whether Humana recklessly disregarded the falsity of the claims it submitted on behalf of its providers, Plaza Medical Centers and Dr. Cavanaugh.

§  Humana contends that “absent evidence that Humana was on notice of alleged fraud, allegations that Humana did not precisely follow its own compliance program—the existence of which negates a finding of the requisite scienter—do not establish the knowing submission or certification of allegedly false diagnosis codes in violation of the FCA.” Motion at 23.  The relator argues that if Humana’s position was true, the defendants could always avoid FCA liability simply by implementing a “compliance program,” no matter how ineffectual.  The relator’s expert avers that “[a]lthough minor lapses in policy may be excused, the record evidence here indicates systematic failure to adhere to internal policies, rendering these policies entirely ineffective as … fraud detection measures.” Anderson Declaration at ¶ 140 (DE# 663-1).

§  The relator relies upon the Ninth Circuit’s decision in United States ex rel. Swoben v. United Healthcare Ins. Co., 832 F.3d 1084, 1098-99 (9th Cir. 2016), amended   F.3d, 2016 WL 7378731 (9th Cir. December 16, 2016), which held that the CMS guidance is (a) “authoritative” because “it provided clear guidance to [MAOs] … regarding their obligations under [42 C.F.R.] § 422.504(l);” (b) created an affirmative obligation to “undertake ‘due diligence’ to ensure the accuracy, completeness, and truthfulness of encounter data [i.e. risk adjustment data] submitted to [CMS];” and (c) imposed an affirmative obligation to make “good faith efforts to certify the accuracy, completeness and truthfulness of encounter data submitted.” Id. (citing 65 Fed. Reg. 40,248 (guidance preamble) (emphasis in original)).  MAOs are also required to “implement an effective compliance program, which must include measures that … prevent, detect, and correct fraud, waste, and abuse.” 42 C.F.R. § 422.503(b)(4)(vi).  In Swoben, the Ninth Circuit vacated and reversed the district court’s dismissal of Swoben’s third amended complaint without leave to amend.  The Ninth Circuit found that Swoben’s theory – “that the defendants designed their retrospective review procedures to not reveal unsupported diagnosis codes, allegedly for no other reason than to avoid reporting that information to the government-- states a cognizable legal theory under the False Claims Act.” 

§  The undersigned finds that the record evidence presents genuine issues of material fact for a jury to determine whether the relator can prove that Humana had the requisite scienter, that is “reckless disregard,” for FCA liability and whether Humana failed to undertake measures constituting a “good faith effort” to certify the truth and accuracy of its submissions to CMS and to maintain an effective compliance plan to detect and correct fraud.  Because there is sufficient evidence in the record upon which a reasonable jury could find for the non-moving party, the relator, this Court should deny Humana’s motion for summary judgment.

§  The reverse false claims provision imposes liability on anyone who “knowingly conceals or knowingly and improperly avoids or decreases an obligation to pay or transmit money or property to the Government.”

§  The Patient Protection and Affordable Care Act of 2010 (“ACA”) requires a person who receives an overpayment of Medicare or Medicaid funds to report and return the overpayment within 60 days of the date on which the overpayment was identified.

§  “[T]he sixty day clock begins ticking when the provider is put on notice of a potential overpayment, rather than the moment when an overpayment is conclusively ascertained, which is compatible with the legislative history of the FCA and the FERA.”

§  The 2014 CMS regulation implementing the 60-day provision of the ACA provides that an MAO “has identified an overpayment when [the entity] has determined, or should have determined through the exercise of reasonable diligence, that [it] has received an overpayment.”

§  “[R]easonable diligence” includes “proactive compliance activities … to monitor for receipt of payments.”

§  The relator acknowledges, as the United States did in its Amicus Brief (Dkt No. 68) in United States ex rel. Swoben v. United States Healthcare Insurance Co., No. 13-56746 (9th Cir. 2016), that “[a]lthough some of the conduct alleged here predates the enactment of the [ACA] and all of the conduct predates the promulgation of CMS’s implementing regulation, these statutory and regulatory overpayment provisions are instructive as to what Congress intended in enacting the reverse-false-claims provision.”

§  Humana disputes that it had knowledge of overpayments and/or knowingly failed to return them within 60 days from when they were identified.  Humana contends that its “voluntary cooperation with DOJ’s investigation of Relator’s allegations precludes a finding that Humana ‘knowingly concealed’ or ‘knowingly and improperly avoided’ the return of alleged overpayments.”

§  The relator contends that the evidence in the record presents a fact question as to whether Humana recklessly disregarded or deliberately ignored overpayments as early as 2010, that is before the complaint was unsealed, and improperly retained those funds until 2016.

§  The relator relies on Humana’s November 2010 PDV Review of Plaza Medical Centers which determined that 35% of the 178 audited diagnostic codes, all of which were previously submitted to CMS, were invalid. The relator argues that this audit alone revealed that Humana had received overpayment for some, if not all, of the 63 invalid diagnostic codes that Humana identified during the November 2010 audit.  Humana waited until February 2016 to submit code deletions for nearly all of those invalidated codes, rather than calculating the resulting overpayments and returning the funds to CMS as it was required to do to avoid liability under 31 U.S.C. § 3729(a)(1)(G).

§  The evidence in the record presents a fact question for a reasonable jury to determine whether Humana had knowledge of and knowingly retained overpayments for improper diagnostic codes that were submitted to CMS.  The relator contends that Humana’s MRA Reviews were similar to the one-sided reviews in Swoben that in practice only captured under-reporting errors that would identify additional diagnosis codes and lead to an increase in payments from CMS.  In Swoben, the Ninth Circuit explained that when an MAO designs reviews that either avoid or conceal over-reporting errors, a lack of diligence and an absence of good faith exist.  Swoben, 2016 WL 7378731, at *10.

§  Humana contends that its cooperation with the Department of Justice’s (“DOJ”) investigation of relator’s allegations absolves it from reverse false claim liability. Humana maintains that its lack of independent investigation into Plaza Medical Centers and Dr. Cavanaugh was justified because:  1) the government declined to intervene; and 2) neither CMS nor DOJ told Humana to investigate its overpayments. 

§  The relator argues that Humana’s duty to investigate is independent of the DOJ’s investigation.  See Crumb, 2016 WL 4480690, at *16 (denying defendants’ motion to dismiss in part because “even in 2014, when [defendants] knew the Government was conducting FCA investigations into [defendants’] alleged false claims … defendants ‘failed to take any corrective or repayment action’” and, by 2015, had only made partial payments).

§  The undersigned finds that genuine issues of material fact exist as to whether Humana is alternatively liable for its knowledge of overpayments and its failure to return the overpayments to the government.






Tuesday, February 7, 2017

Advanced Risk Adjustment and CDI Workshop


JOIN US FOR A DAY OF RISK ADJUSTMENT


       JOIN US:  THURSDAY MARCH 23, 2017                                    FROM:  9:30 AM TO 3:30 PM
       
       LOCATION:   1451 W CYPRESS CREEK ROAD,  FT.  LAUDERDALE, FL, 33309

  • Review the different risk adjustment models and their impact on medical practice management.
  • Discuss the impact of shifting from RAPS to EDS. What does this mean for office based claims?
  • Take a deep dive into HCC Coding and Documentation. 
           Review real examples to see what validates, what doesn’t and why.  
           Plus, tips for engaging physicians.

  • Learn how to leverage frontline staff to be successful in the world of risk adjustment and value based payments. 



WHO SHOULD ATTEND?
             
  •     Medical Coders and Billers
  •     Providers, Managers and Frontline Staff
  •     CDI Specialists
  •     Executive Leaders
  •     ACO, MSO and IPA Teams
          
 Click HERE  to View Agenda   or   Click HERE to REGISTER


        Email Kameron Gifford for more information


  

Saturday, December 10, 2016

OIG Expands Kickback Safe Harbors While Expanding Bases for CMP



The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services has finalized its newest safe harbor rule that had been pending for two years. The rule, titled "Medicare and State Health Care Programs: Fraud and Abuse; Revisions to the Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements," attempts to provide flexibility in new cost-sharing arrangements by preventing certain initiatives by doctors, hospitals and pharmacies from being treated as fraudulent kickbacks by Medicare and Medicaid.
The OIG's new rule amends the federal Anti-Kickback Statute and expands the safe harbors for patients covered in federal healthcare programs for the following activities:
  • Waiver by a hospital for cost-sharing imposed under a Federal healthcare program if certain conditions are met;
  • Waiver of cost-sharing amounts owed to a federally qualified health center;
  • Waiver by a pharmacy for cost-sharing imposed by a federal healthcare program under certain conditions;
  • Free or discounted local transportation services if certain conditions are met; and
  • Waiver of cost-sharing for emergency use of state or municipality-owned ambulance services to transport patients within a radius of 25 miles in urban settings and 50 miles in rural settings to physicians' offices, hospitals, home health agencies, pharmacies and laboratories.
The rule also excludes the following from the definition of "remuneration" in connection with liability under the Civil Monetary Penalties [CMPs], Assessments and Exclusions law:
  • Differentials in cost sharing as part of a benefit design so long as the differentials are disclosed;
  • Items or services that improve a beneficiary's ability to obtain items and services payable by Medicare or Medicaid and that pose a low risk of harm to such beneficiary by being unlikely to interfere with clinical decision making, raise patient safety issues, or lead to improper utilization;
  • Coupons, rewards or rebates that are available on equal terms to the general public; and
  • Free items to persons with financial need if they are not offered as part of any advertisement or solicitation or tied to the provision of other services.
    On the flip side, the final rule allows for CMPs for not granting the OIG access to records in a timely manner, ordering or prescribing while already excluded from government health care programs, making false statements, omissions or misrepresentations when applying for enrollment, not reporting or returning overpayments and using false records or materials that are material to false or fraudulent claims. The OIG decline to make any change in the six-year statute of limitations for bringing exclusion actions.

    The final rule was published in the Federal Register on December 7.





Friday, December 9, 2016

Rapid Practice Innovation



What is Rapid Practice Innovation?

You can’t manage healthcare today, with yesterday’s models, and be in business tomorrow...
In the context of education, is it culture or strategy that drives our desire for something better? In terms of change, is it more power or responsibility that one is seeking? And what has enabled some leaders to drive mass change across large organizations while others fail? Perhaps the single greatest predictor is the power of influence, the human factor that encourages and sustains the necessary energy to get to that point of “something better.”
The process of identifying and eliminating waste and ultimately defects was made famous by Toyota and has since infiltrated every other industry on some level. But can process improvements alone be enough to tackle the bureaucracy of America’s healthcare system? Can regulatory reform inspire those farthest from Congressional hill, those who return to the front lines day after day to care for our aging population of seniors or will it take something more?
The path of progress must not be paved in external motivation alone but incite the flames of internal desires to be effective. If the agent of change is not truly embodied in the cause themselves, then can the message accurately be broadcast from payer to provider to consumer or is it lost in translation?
As a consultant, an educator, or a trainer, it is that single moment of transition from external to internal, that aha moment, if you will, that keeps us coming back again and again. Empirical Risk Management was founded on the belief that change, must be initiated at the initial point of contact to be effective, and in managed care that means the process must begin when the patient walks in the door.
Over the last week, my team and I were once again taken aback at the power of an individual to influence and inspire those around them. In Miami, Florida just a few blocks from downtown, we witnessed progress first hand. Halfway down the street on the left hand side is a small brown house whose driveway stays full of patients waiting to be seen. But this is not your typical practice, inside you will find a leader, whose charge for change begins with strength and whose passion resonates within all four walls. The epitome of a healer, a champion of champions.
Our call to action was prompted by a desire to improve the “team” and to create a shared vision for the future. Our mission was not defined by reaction, but instead action, originating from that desire for something better. We were not there to “fix” a specific problem, but instead to observe, assess, and to improve if at all possible. These projects, coined RPI or rapid practice innovation, are not for the faint of heart, and in fact the obscurity of the task often leads most to shy away. However, it is that exact uncertainty that elicits my passion. For isn’t it the shared success of the sum that is greater than the individual triumphs?
The value that is derived from a receptionist who understands the clinical significance of a 1% improvement in a Hgb A1c will far exceed the value of your investment. A nurse who understands the 10 guiding principles that influenced the creation of the CMS-HCC model will inherently improve the experience for both the provider and the health plan. A coder who understands the potential financial impact of rejected encounters on the Medicare Advantage plan will provide incredible value to your revenue cycle. It is this proactive team approach at the initial point of contact that ultimately improves outcomes and minimizes opportunities for errors.
And at the end of the day, it is this shared vision, that unites once starkly contrasting goals into one uniformed march towards optimization.

Download a simple framework for guidance on implementing RPI within your organization.
Rapid Practice / Plan Innovation
These tools will assist organizations in implementing RPI with their organizations.
RPI Tools.pdf 
Adobe Acrobat document [372.4 KB]

Sunday, December 4, 2016

Advanced Risk Management and Office Based CDI Workshop

JOIN US  WEDNESDAY FEBRUARY 22, 2017  
FROM: 9:30 AM - 3:30 PM
LOCATION: BOCA OFFICE CENTER, 6501 CONGRESS  AVENUE, BOCA RATON, FL 33487



TOPICS:
  • Review the different risk adjustment models and their impact on medical practice management. 
  • Discuss the impact of shifting from RAPS to EDS. What does this mean for office based claims? 
  • Take a deep dive into HCC Coding and Documentation. Review real examples to see what validates, what doesn’t, and why. Tips for engaging physicians. 
  • Learn how to leverage frontline staff to be successful in the world of risk adjustment and value based payments.  

EACH ATTENDEE WILL RECEIVE:
  • Clinical Documentation and Coding Guide  $ 99 Value
  • HCC Quick Coder (Mappings to ICD-10 Codes) for MA and Commercial Models
  • Risk Adjustment Workbook and Appendix with Easy to Use Templates
  • Laminated Coding and Documentation Tools 

WHO SHOULD ATTEND?
  • Medical Coders and Billers
  • Providers, Managers and Frontline Staff
  • CDI Specialists
  • Executive Leaders
  • ACO, MSO and IPA Teams



APPROVED FOR 6 HOURS OF CEU's by  AAPC


Download
Download the Workshop Agenda
Join us for a full day of risk adjustment at the 4th Annual Tri-County Workshop. Seating is Limited. Register Today!
ERM ARM and CDI Workshop.pdf 
Adobe Acrobat document [449.5 KB]



Speakers

  
Kameron Gifford, CPC

Kameron is the founder and Chief Executive Officer of ERM Consulting and mHealth Games, an online learning company. Over the last 17 years she has worked hand in hand with physicians, managed care organizations, hospitals and health plans to develop efficient billing practices, implement value added processes and improve the entire experience of care for their patients. Kameron is passionate about risk adjustment and a strong advocate for frontline staff.

Kameron is also a primary author of several national risk adjustment workshops produced by RISE and Healthcare Education Associates: 
  • Risk Adjustment 101
  • HCC Coding Accuracy

And Co-author of the new RISE Workshop 
  • Advanced HCC Coding



Todd Gifford, MBA, Ph.D, CRC

Todd is a Director of Finance for a large Medicare Advantage MSO based in Miami, Florida. He joined them in 2007 as Managing Director of Health Solutions UK, a joint venture with Humana. During his two and a half years in London he worked hand in hand with the NHS to transform the way care was delivered. From 2010 to 2012, Todd oversaw the start-up expansion into Texas. In this role, he was responsible for 12,500 MA members and a budget of $75m.

Todd graduated from the University of Arkansas with a B.A. in 1991, and received his MBA from Webster University in 2001. He was awarded a Ph.D in Business from Woodfield University in 2013.

In addition, Todd is also the Co-founder of mHealth Games, an innovative technology company headquartered in Miami, Florida.


Register Online for the Workshop




Monday, August 15, 2016

FREE AAPC CEUs


















At least once a week, I get a request for free CEUs. Often these are last minute frantic requests from coders who are less than 48 hours away from their AAPC deadline.  This can be a terrifying moment for both the coder and the organization that employs them.

It was those moments that inspired us to create ERM Academy.  A collaboration between ERM Consulting and mHealth Games that aims to bring high quality, on-demand education and training to all frontline staff.


For a limited time, ICD-10 Coding Guidelines for 2016, approved by the AAPC for 8 hours, will be included FREE with all Annual Memberships. That is a $199 value FREE!

 How it Works?

  1.  Visit ERM Academy
  2. Register for an Annual Account
  3. Launch Course
  4. Review Course Content
  5. Complete Final Assessment 
  6. Download Certificate
Questions?

·        Email kgifford@ermconsultinginc.com




    Sunday, August 14, 2016

    MACRA Challenge
















    What is MACRA? Who does it effect? What is the timeline for implementation? How does quality factor into the equation?
    Do you know the answer to these questions? If so, then take the MACRA challenge today!

    Click on the picture above to play...



    Saturday, August 13, 2016

    CDI Speedway




    Complete and accurate ICD-10 coding is driven by complete and accurate encounter documentation.

    Test your clinical documentation skills on the CDI SPEEDWAY and see if you what it takes to cross the finish line first.


    Another game from ERM ACADEMY


         Click the picture above to launch....



    E/M Coding Trivia



    Are you looking for new an innovative ways to train your staff? If so, you will love this new game from mHealth Games! 

    Click on the picture below to play game....




    Are you a champion of coding E/M services? Do you have what it takes to correctly identify a 99213 vs. a 99214? 

    If so, you could be the next winner of E/M Coding Trivia.









    Friday, March 4, 2016

    Provider User-Experience Challenge


    Action

    Notice.

    Summary

    Like the Consumer Health Data Aggregator Challenge, the Provider User-Experience Challenge incents the development of applications for health care providers that use open, standardized APIs to enable innovative ways for providers to interact with patient health data. This challenge will focus on demonstrating how data made accessible to apps through Application Programming Interfaces (APIs) can positively impact providers' experience with EHRs by making clinical workflows more intuitive, specific to clinical specialty, and actionable. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111-358).

    DATES:

    Phase 1
    • Challenge launch: March 1, 2016
    • Submissions due: May 30
    • Evaluation period: May 31-June 28
    • Phase 1 winners announced: June 30
    Phase 2
    • Submission period begins: May 31
    • Submissions due: November 7
    • Evaluation period: November 14-December 14
    • Phase 2 winners announced: December 15, 2016
    FOR FURTHER INFORMATION CONTACT:

    Adam Wong, adam.wong@hhs.gov (preferred), 202-720-2866.

    SUPPLEMENTARY INFORMATION:

    Award Approving Official

    Karen DeSalvo, National Coordinator for Health Information Technology.

    Subject of Challenge Competition

    The Provider User-Experience Challenge is intended to spur development of third-party applications for use by clinicians and use FHIR to pull various patient health data into a dashboard. The challenge has two phases—the first requiring submission of technical and business plans for the application (app), the second a working app that is available for providers. Phase 2 of the competition will not be limited to only those who won Phase 1—all Phase 1 competitors, and those who did not participate in Phase 1, can submit a final app at the end of Phase 2.

    The final application must meet the following requirements:
    • Uses FHIR Draft Standard for Technical Use 2 (DSTU2)
    • Aggregate all data as specified in the 2015 Edition Common Clinical Data Set (Data column in https://www.healthit.gov/sites/default/files/commonclinicaldataset_ml_11-4-15.pdf)
    • Verified compatibility with different health IT developer systems implemented in production settings, 1 of which must be from the top 10 systems measured by Meaningful Use attestation per HealthIT.gov. Apps must be integrated with a minimum of 3 unique health IT developer systems in 2 unique provider settings
    • Has been tested with patients and used in production settings
    • Available to providers through at least one of the following modes: Direct from Web, iOS Store, or Android stores
    Phase 1

    Participants interested in competing for Phase 1 awards will need to submit an app development plan that must include:
    • Mockup/wireframes
    • Technical specifications, including but not limited to planned data sources, system architecture
    • Business/sustainability plan
    • Provider partnership
    To augment technical development and enhance the likelihood of a successful app that will continue to exist beyond the end of the challenge, a progress update/matchmaking event will be held that will seek to connect participants with provider partners. Up to five app proposals will be recognized as winners and awarded up to $15,000 each.

    Phase 2

    The second phase will entail the actual development of the apps, verification of technical capabilities, user testing/piloting, and public release of the apps. This will include remote testing with providers and health IT developers to test the technical abilities of the apps to connect to in-production systems. Participants will submit:
    • Working prototype of the app
    • Video demonstrating the app (maximum of 5 minutes, on YouTube or Vimeo)
    • Slide deck describing app (maximum of 10 slides)
    The grand prize winner will receive $50,000 and a second place winner will receive $25,000. There will be an additional $25,000 prize for the app that connects to the greatest number of unique health IT developer systems implemented in production settings, which can be won by the grand or 2nd place winner.

    Eligibility Rules for Participating in the Competition: To be eligible to win a prize under this challenge, an individual or entity:
    1. Shall have registered to participate in the competition under the rules promulgated by the Office of the National Coordinator for Health Information Technology.
    2. Shall have complied with all the requirements under this section.
    3. In the case of a private entity, shall be incorporated in and maintain a primary place of business in the United States, and in the case of an individual, whether participating singly or in a group, shall be a citizen or permanent resident of the United States.
    4. May not be a Federal entity or Federal employee acting within the scope of their employment.
    5. Shall not be an HHS employee working on their applications or submissions during assigned duty hours.
    6. Shall not be an employee of the Office of the National Coordinator for Health IT.
    7. Federal grantees may not use Federal funds to develop COMPETES Act challenge applications unless consistent with the purpose of their grant award.
    8. Federal contractors may not use Federal funds from a contract to develop COMPETES Act challenge applications or to fund efforts in support of a COMPETES Act challenge submission.
    An individual or entity shall not be deemed ineligible because the individual or entity used Federal facilities or consulted with Federal employees during a competition if the facilities and employees are made available to all individuals and entities participating in the competition on an equitable basis.
    Entrants must agree to assume any and all risks and waive claims against the Federal Government and its related entities, except in the case of willful misconduct, for any injury, death, damage, or loss of property, revenue, or profits, whether direct, indirect, or consequential, arising from my participation in this prize contest, whether the injury, death, damage, or loss arises through negligence or otherwise.

    Entrants must also agree to indemnify the Federal Government against third party claims for damages arising from or related to competition activities.

    Submission Requirements
    In order for a submission to be eligible to win this Challenge, it must meet the following requirements:
    1. No HHS or ONC logo—The product must not use HHS' or ONC's logos or official seals and must not claim endorsement.
    2. Functionality/Accuracy—A product may be disqualified if it fails to function as expressed in the description provided by the user, or if it provides inaccurate or incomplete information.
    3. Security—Submissions must be free of malware. Contestant agrees that ONC may conduct testing on the product to determine whether malware or other security threats may be present. ONC may disqualify the product if, in ONC's judgment, the app may damage government or others' equipment or operating environment.

    Registration Process for Participants: To register for this Challenge, participants can access http://www.challenge.gov and search for “Provider User-Experience Challenge.”

    Prize
    • Phase 1: Up to 5 winners each receive up to $15,000.
    • Phase 2: One final winner receives $50,000; 2nd place receives $25,000; and an additional $25,000 connector prize.
    • Total: Up to $175,000 in prizes.
    Payment of the Prize: Prize will be paid by contractor.
    Basis Upon Which Winner Will Be Selected: The review panel will make selections based upon the following criteria:

    Phase 1
    • Technical feasibility of plan, including number of EHR sources targeted.
    • Adherence to data privacy and security best practices.
    • Strength of business/sustainability plan.
    • Impact potential in clinical setting.
    • Provider and/or health IT developer partnerships.
    Phase 2
    • Number, sources, and types of data aggregation using FHIR.
    • Functionality and quality of data aggregation.
    • Privacy and security of patient data.
    • Impact potential in clinical setting.
    • User experience and visual appeal.

    Additional Information

    General Conditions: ONC reserves the right to cancel, suspend, and/or modify the Contest, or any part of it, for any reason, at ONC's sole discretion.

    Intellectual Property: 
    Each entrant retains title and full ownership in and to their submission. Entrants expressly reserve all intellectual property rights not expressly granted under the challenge agreement. By participating in the challenge, each entrant hereby irrevocably grants to Sponsor and Administrator a limited, non-exclusive, royalty-free, worldwide license and right to reproduce, publically perform, publically display, and use the Submission to the extent necessary to administer the challenge, and to publically perform and publically display the Submission, including, without limitation, for advertising and promotional purposes relating to the challenge.

    Authority:

    Dated: February 23, 2016.
    Karen DeSalvo,
    National Coordinator for Health Information Technology.
    [FR Doc. 2016-04466 Filed 3-1-16; 11:15 am]

    BILLING CODE 4150-45-P