Big Data: Navigating the Recent and Pending Releases of CMS Data Sets

Big Data: Navigating the Recent and

Pending Releases of CMS Data Sets

Bernard J. Ford, Navigant Consulting, Inc.

Benjamin Koplin, Fulbright & Jaworski LLP (Norton Rose Fulbright) Lesley Reynolds, Fulbright & Jaworski LLP (Norton Rose Fulbright) June 4, 2014

Speaker

Partner, Fulbright & Jaworski LLP (Norton Rose Fulbright)

As a Partner in the Washington, D.C. office, Lesley Reynolds focuses her

practice on matters involving health care compliance and litigation. Lesley has worked with clients including hospitals, managed care organizations,

pharmaceutical companies, medical device manufacturers, LTACHs, hospices, medical schools and other health care entities.

Lesley's practice includes the representation of health care clients in

compliance matters, including internal investigations and self-disclosures. Lesley also has represented hospitals and health systems in litigation involving hospital charges and collections from the uninsured in both state and federal courts. Through her practice, Lesley has worked extensively on class action issues affecting health care clients.

Previously, Lesley had experience working in the office of in-house counsel at a health maintenance organization in the Washington, D.C. area.

Speaker

Senior associate, Fulbright & Jaworski LLP (Norton Rose Fulbright)

Senior Associate Benjamin Koplin practices in the Austin office. He

focuses primarily on health care compliance and the federal regulation of health care providers and suppliers through agency actions, the Anti-Kickback Statute, the Stark Law, state and federal false claims acts, and the privacy and security of health information (HIPAA), as well as assisting in design and implementation of corporate compliance programs and various transactional matters involving health care entities.

Speaker

Managing Director, Navigant Consulting, Inc.

Mr. Ford is a Managing Director at Navigant Consulting with thirty years of consulting experience. He regularly leads large, complex health care litigation, compliance, and advisory services engagements and has significant experience in investigations, litigation, and compliance matters involving health care providers and life sciences companies. Bernie has assisted clients in many high-profile US civil and criminal investigations including matters involving alleged bribery, off-label

promotion, Medicare and Medicaid fraud, and alleged violations of the Anti-Kickback Statute, Physician Self-Referral (Stark) Laws, False Claims Act, Food, Drug &

Cosmetics Act, and Foreign Corrupt Practices Act. He has performed contract and pricing analyses, investigated Medicare and Medicaid disputes of many kinds, performed numerous damages computations, and has assisted in negotiating settlements with private litigants and government entities. He has served as a consultant and advisor to counsel for many of the largest US drug company fraud settlements involving alleged illegal marketing conduct and has conducted many projects involving the investigation of clinical studies and other aspects of clinical research. Bernie has applied the knowledge gained in analyzing disputes by assisting companies in compliance assessment and implementation engagements as well as conducting CIA IRO engagements. His role on engagements often requires preparing analyses and findings for presentation to and discussion with executive management, Boards of Directors, regulators and enforcement agencies including delivering expert testimony. He is the editor of the Navigant's False Claims Act Case Tracker and serves as a speaker and author on fraud, investigations, and compliance.

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What We'll Cover

Overview: What is in the two Big Data sets? Basic statistics from the Part B data

What we know and don’t know about the data Takeaways

• How will the relators' bar use the data?

Two Big Data Sets

Big data: Navigating the Recent and Pending Releases of CMS Data Sets 8

Part B Utilization

Over 9 million lines of data from CY 2012 National Claims

History Standard Analytic Files—drawn from only “final action” claims for FFS

beneficiaries

Data regarding services

provided by physicians, non-physician practitioners,

laboratories, imaging, ambulances, etc. (but not DMEPOS)

Includes provider demographics (name, credentials, gender,

complete address and entity type)

Sunshine Act/Open Payments

Millions of lines of data relating to payments/transfers

directly/indirectly to physicians and teaching hospitals from manufacturers, direct/indirect ownership interests held by physicians in manufacturers and GPOs

Physician identifying info

included similar to Part B data set

Transaction level details

showing “form” and regarding reason for payment

Provider Utilization and Payment Data Statistics

2012 data released by CMS on April 9, 2014

• Contains 880,000 distinct health care providers

• $77 billion in Medicare Part B Fee-for-Service payments • The data represents the final action on all claims

• File is aggregated/summarized by Provider, HCPCS, and Place of Service

Between April 9, 2014 – May 28, 2014

10

The data have been

downloaded or accessed more

than

300,000

times

- Over 6,000 downloads or accesses a day

What Do We Know About the Data

CMS's intent in releasing the data sets

Who wants to see the data

Significant inter-agency coordination and increased

use of data mining

What is Unclear in the Part B Data

12

Does not reflect all Medicare spending May not accurately show true claims • Summaries of data billed by providers • Errors not necessarily scrubbed out Does not provide physician-level profit Does not show all 2012 FFS claims

• Excludes provider-level services on less than 10 beneficiaries • Excludes DME

Does not show all 2012 FFS services

Conflict between the provider-level services that do not show “performing provider” claim specs

Does not show facility fees

What is Unclear in the Part B Data

• Does not show valid modifiers that contribute to variance in “allowed payment” and “payment”

• Does not address risk-adjustments to account for variance in patient conditions

• Does not show differences in billing units

• Significantly limited list of included provider types • Does not address quality/performance indicators

Open Payments Data Limitations

14

• Data collected solely for reporting (not for payment) • Adoption rates vary

• Wide variance in operationalization affecting reports

• Wide variance in risk determinations vis-à-vis tracking and reporting

• Existing contracting relationships drive data collection and validation

• Too many chefs in the kitchen

How Will (or Have) the Data Sets be Used

The datasets will be used, but how? Enforcement agencies?

Private litigants?

• Relators? Note the FCA’s "original source" exception to the public disclosure bar: (31 USC § 3730)

–Courts must dismiss (unless opposed by gov't) qui tam actions based on

information previously and "publicly disclosed . . . in a . . . Federal report . . . ."

–Unless the relator "has knowledge that is independent of and materially adds to

the publicly disclosed . . . transactions . . . ."

Provider and Industry Concerns: Part B Data

16

• Amount paid to physicians does not reflect cost to provide services

• High cost specialties are singled out

• Services may be performed by residents, physician assistances, or nurse practitioners under physician NPI

• Does not include information on all patients, which does not allow for complete picture when making comparisons among providers

Provider and Industry Concerns: Sunshine Act Data

• Conflicting CMS guidance

• Wide variation in interpretation, business arrangements affect reporting

• Low awareness/understanding on part of transaction partners, Covered Recipients

Best Practices Moving Forward

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• Know if you are an outlier – because someone else will • Understand the risks of inaccurate perceptions

• Make sure staff is prepared for media inquiries

• Ensure that you are reviewing information in a way that does not create additional risk

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