WP069 DM Requirements for Physician Payment Transactions

8/9/2019 WP069 DM Requirements for Physician Payment Transactions

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Data Management

Requirements for PhysicianPayment Transactions

A DataFlux White PaperPrepared by David Loshin


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IntroductionBetween the years 1996 and 2005, the annual spending on pharmaceutical industry

direct-to-consumer marketing, advertising and promotion to health care

professionals rose from $11 billion to practically $30 billion. By 2005, the majority of

that activity consisted of professional promotion and over $18 billion worth of free

samples.1 For the pharmaceutical industry, this significant marketing investment is a

double-edged sword while it promotes awareness of drugs and devices to the

health care provider community, payments by drug, device and medical supply

companies to medical practitioners might be construed as influencing practitioner

decisions. The risk lies in the potential for creating a conflict of interest on behalf of

that same community of health care practitioners, leading to concerns about the

objectivity of physicians and, ultimately, patient safety.

There has been a growing sentiment that establishing rules for physician payment

transparency would reduce the impact of pharmaceutical marketing and promoteawareness of appropriate prescription and drug safety. While many states already

have laws requiring pharmaceutical and medical device manufacturers to publicly

report gifts and payments made to physicians and other health care practitioners and

providers, provisions for physician payment transparency were included in the Patient

Protection and Affordable Care Act of 2009 (H.R. 3590, section 6002), which was

signed into law on March 23, 2010.

The inclusion of these provisions in the health care reform legislation has

consequences for the pharmaceutical and medical device industry with respect to the

ability to capture, manage and organize data in order to generate reports to support

compliance with the transparency reporting directives. This paper explores just a few

of the data management requirements necessary to support compliance with the

reporting requirements for physician payment transparency and disclosure.

Using the text of the federal legislation as a starting point, the paper first seeks to

understand how some of the key data concepts factor into compliance reporting.

Next, the paper discusses the complexity of the reporting requirements, challenges

to establishing the proper business processes for documenting transfers of value,

and the need for analytic reporting. Finally, after reviewing the dependence on high

quality data, the paper suggests that ancillary benefits can be achieved as a

byproduct of instituting best practices for data quality and data governance.

1 Julie M. Donohue, Ph.D., Marisa Cevasco, B.A., and Meredith B. Rosenthal, Ph.D. ,

A Decade of Direct-to-Consumer Advertising of Prescription Drugs, NEJM August

16, 2007, accessed via http://content.nejm.org/cgi/content/full/357/7/673.


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Physician Payment Transparency Provisions Information IssuesUnderstanding the compliance reporting implications of physician payment

transparency with respect to information management begins with a review of theactual language of the health care reform legislation. This excerpt, which is taken

from section 1128G(a)(1)(A) of the physician payments sunshine provision of the

Patient Protection Affordable Care Act, states that on an annual basis,

any applicable manufacturer that provides a payment or other transfer ofvalue to a covered recipient (or to an entity or individual at the request of ordesignated on behalf of a covered recipient), shall submit to the Secretary, insuch electronic form as the Secretary shall require the following informationwith respect to the preceding calendar year:

i. The name of the covered recipient.

ii. The business address of the covered recipient and, in the case of a coveredrecipient who is a physician, the specialty and Medicare billing number of thecovered recipient.

iii. The value of the payment or other transfer of value.

iv. The dates on which the payment or other transfer of value was provided tothe covered recipient.

v. A description of the form of the payment or other transfer of value,indicated as

(I) cash or a cash equivalent;

(II) in-kind items or services;

(III) stock, a stock option, or any other ownership interest, dividend, profit,or other return on investment; or

(IV) any other form of payment or other transfer of value (as defined by theSecretary).

vi. A description of the nature of the payment or other transfer of value,indicated (as appropriate for all that apply) as

(I) consulting fees;

(II) compensation for services other than consulting;

(III) honoraria;

(IV) gift;

(V) entertainment;

(VI) food;

(VII) travel (including the specified destinations);

(VIII) education;


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(IX) research;

(X) charitable contribution;

(XI) royalty or license;

(XII) current or prospective ownership or investment interest;

(XIII) compensation for serving as faculty or as a speaker for a continuingmedical education program;

(XIV) grant; or

(XV) any other nature of the payment or other transfer of value (as definedby the Secretary).

vii. If the payment or other transfer of value is related to marketing, education,or research specific to a covered drug, device, biological, or medical supply,the name of that covered drug, device, biological, or medical supply

viii. Any other categories of information regarding the payment or othertransfer of value the Secretary determines appropriate

Section 1128G(a)(2) goes on to say that also, on a yearly basis,

any applicable manufacturer or applicable group purchasing organizationshall submit to the Secretary, in such electronic form as the Secretary shallrequire, the following information regarding any ownership or investmentinterest (other than an ownership or investment interest in a publicly tradedsecurity and mutual fund, as described in section 1877(c)) held by a physician(or an immediate family member of such physician (as defined for purposes ofsection 1877(a)) in the applicable manufacturer or applicable group purchasing

organization during the preceding year:

(A) The dollar amount invested by each physician holding such an ownership orinvestment interest.

(B) The value and terms of each such ownership or investment interest.

(C) Any payment or other transfer of value provided to a physician holdingsuch an ownership or investment interest (or to an entity or individual at therequest of or designated on behalf of a physician holding such an ownership orinvestment interest), including the information described in clauses (i) through(viii) of paragraph (1)(A), except that in applying such clauses, physician shallbe substituted for covered recipient each place it appears.

(D) Any other information regarding the ownership or investment interest theSecretary determines appropriate.

DefinitionsCompliance reporting is directly tied with clear definitions associated with some key

phrases that merit further consideration. Luckily, the legislation conveys some

semantics associated with some of these terms, which provide the starting point for


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review. In a few situations, these concepts are broader than one might anticipate,

while in some cases defined exclusions reduce the scope of what might be covered.

Some key phrases include:

Applicable manufacturer, meaning a manufacturer of a covered drug,device, biological or medical supply, which is operating in the United Statesor one of its territories, possessions or commonwealths

Covered recipient, defined as a physician or a teaching hospital Payment or transfer of value, which is (not surprisingly) a transfer of

anything of value

Applicable group purchasing organization, which is an organization thatpurchases, arranges for, or negotiates the purchase of a covered drug,

device, biological or medical supply, operating in the United States or one of

its territories, possessions or commonwealths

Physician (or an immediate family member of such physician), whichincludes a doctor of medicine or osteopathy, a doctor of dental surgery or

medicine, a doctor of podiatric medicine, a doctor of optometry or a

chiropractor

The definitions provided may be adequate for descriptive purposes, but do pose one

question: can a reporting organization rely on these definitions (for the different

entities and data concepts), as defined within the text, for isolation and

differentiation?

Reporting Requirements Public AvailabilityNot only are applicable manufacturers and distributors required to provide reports,

the law specifies some criteria with respect to the way the data is made available(presumably by the federal agencies involved) to the public. However, the need to

present the information as described imposes additional expectations for reporting.

Specifically, the information must be made available to the public through a website,

must be searchable, easily aggregated and downloaded, and contain the information

presented by:

The name of the applicable manufacturer or group purchasing organization The name of the covered recipient The business address of the covered recipient The medical specialty of the covered recipient The value of the payment or transfer of value The date on which the payment or transfer of value was made to the covered

recipient

The form of the payment or transfer of value The nature of the payment or transfer of value The name of the covered drug, device, or medical supply


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Clearly, this directive for public availability of the data is intended to help individuals

research the potential for pharmaceutical and distributor influence over health care

practitioners. The directive for public reporting suggests an even broader scope of

data to be managed, suggesting that a system of record containing information

about the covered recipients must be available to ensure accurate and completereporting.

Business Process, Data Capture, and AggregationBecause of the nature of marketing practices, the very broad range of business

processes involved suggest some complexity when it comes to transparency

reporting, and the diversity of participants and documentation processes can lead to

questions associated with compliance. Clarification of what are covered devices is

necessary in determining whether an organization is an applicable manufacturer and

is obliged to report. Significant variations of data associated with physicians,

practices, health care organizations, etc., complicate the tracking of associations with

covered recipients, especially when there is a need for tracking ownership interestsassociated with each physicians immediate family members. And, as described in

the text, transfer of value is much broader than a cash payment. It essentially

covers any of a number of specific items provided by the manufacturer to the

covered recipient (including, among other items, consulting fees, compensation for

services other than consulting, honoraria, gifts, entertainment, food, travel,

education, research and charitable contributions). However, some items are explicitly

(and surprisingly) excluded, such as items of which the value is less than $10, product

samples and loans of covered devices for short-term periods.

Data Management ImplicationsAt the highest level, the data management professional can clearly see that

externally-imposed business (in this case, compliance) policies are directly related to

correlated information management requirements. And, in turn, the existence of

these direct relationships should, to some extent, allay some anxiety with respect to

the feasibility of compliance. Through the identification and evaluation of some key

data management implications, an organization can combine the right tools,

techniques and data governance to efficiently engineer a reporting solution that best

fits their needs.

Data Completeness and ConsistencyTo properly comply with the laws provisions, an applicable manufacturer must be

able to provide data documenting the transfer of value, along with associated details

that go beyond the specifics of the exchange. The manufacturer must be able to

provide that associated information about the recipient such as business address

and specialty. The data provided must be consistent across all transactions

associated with each covered recipient. This is necessary to satisfy the public

reporting requirements so that the data can be searched and aggregated by the

variables indicated earlier in this paper.


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The implication is that the organization must institute data validations and controls to

ensure that, at the time that the transactions are logged, all the required data values

are present. In addition, these controls can be used to verify that the data values

observe validity and reasonability expectations. An additional implication is that the

organization must be able to be able to extract records from each of the sourcesystems and to consolidate records drawn from multiple data sets, suggesting a

need for data integration tools and techniques.

Semantics and MetadataThe wording of the legislation is particular about the concepts that must be reported.

However, the definitions provided within the text may or may not directly relate to

definitions for the same or similar concepts managed within each applicable

manufacturer. Essentially, it is up to each reporting organization to identify how those

definitions map to internally documented activities and parties

There are two data management implications associated with metadata. The first isthe need for an assessment of the types of parties that might be subject to this rule,

to qualify the internal definitions and ensure that the internal definitions can be

mapped to the definitions provided in the regulation. The second data management

implication is that the manufacturer must catalog which systems contain data

regarding relevant transactions and be able to standardize the data values in those

data sets into a format suitable for sharing. This implication suggests requirements

for metadata management and techniques for data standardization.

Ontologies and HierarchiesThe simplicity of the definitions also hides some complexity associated with the

ability for reporting, roll-ups, and ultimately, public transparency and accessibility.Reporting information regarding ownership or investment interest is not limited to

physician, but also includes specific related parties. This implies a need by the

reporting organization to identify and track ownership and investment interests held

by physicians as well as their immediate family members, requiring identity resolution

and data householding.

The push for transparency is directly tied to the public availability of the data that can

be easily aggregated by a number of variables, particularly related to the

characteristics of physician payments and transfers of value as described in section

1128G(a)(1)(A). This introduces additional implications related to the need for

classifying (and thereby aggregating) the natures of payment or transfer of value as

well as the need for classifying (and thereby aggregating) the form of payment or

transfer of value. Correspondingly, this implies the ability to manage the master

reference data that defines those classifications and hierarchies.

Payments and Transfer of ValueAlthough section 1128G(a)(1)(A)(vii) describes the different nature of payments and

transfers of value, each of the categories listed might incorporate a wide variety of


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items. This suggests that the business processes for logging and tracking direct

physician marketing must be precise enough to capture the specific item provided to

the covered recipient. However, with a wide population of individuals operating in

different geographic regions, with varying names for similar items, there is a great

potential for variance in describing the transfer of value, even for identical items.

The implication for data management is that the reporting organization should use

master reference data to classify data values in preparation for subsequent

aggregation. This also means that there must be tools and techniques for scanning

and parsing those data values, which can be mapped using business rules to the

reference classifications.

ReportingApplicable manufacturers and distributors are likely to be measured as compliant or

non-compliant in terms of their ability to observe the reporting requirement. This

ultimately is reflected not just as a series of transactions, but (as suggested by theprovisions for public access) must allow for aggregation and reporting of total

marketing spend to covered recipients by the different classes of transfer of value.

The data management implication is a requirement for a process for data extraction,

consolidation and normalization into a format suitable for searching and

aggregation.

AuditabilityNot only must there be a process for collecting, managing and reporting payments

and transfers of value, those processes used for documentation and reporting

themselves must be auditable, for purposes of validation and protection against

claims of failure to knowingly report required information. The implication for data

management is the need for a governed level of maturity with respect to the

processes for reporting. The processes for extraction, consolidation and preparation

must be defined, documented and repeatable.

Information Management Best Practices forComplianceFortunately, there are some commonalities across the data management implications

that can potentially reduce the complexity of reporting compliance for physician

transparency:

Data assessment and semantic harmonization Metadata and master reference data management Parsing, standardization and identity resolution tools and techniques Data integration Data governance


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Data Assessment and Semantic HarmonizationProcesses for determining which business terms and corresponding data element

definitions represent data values subject to reporting employ data assessment

techniques such as data profiling combined with a top-down evaluation of existing

business concepts and metadata. Scanning the data sources and reviewing theresults of a bottom-up statistical evaluation with business subject matter experts

provide the fundamental approach for semantic harmonization.

Metadata and Master Data ManagementOne result of a data assessment is the identification of reference data entities that

can be isolated for resolution. These master data concepts are particularly valuable,

especially when it comes to classification and aggregation. Master data management

techniques are data management best practices that can be employed to assist in

tracking critical information:

Reference data associated with the different types of payments Recipient data associated with the physicians and teaching hospitals Product data associated with the covered drugs, devices, biological, or

medical supplies

Clinical trial data associated with investigations and trialsMaster reference data management techniques also help manage associated

hierarchies and classifications, associated consolidation rules (such as those used for

resolving geographic scope for organizations or for managing corporate parent

structure) and relationship discovery and management to provide the ability to work

with data about individuals and organizations in same repository. Existing identifying

attributes can be used to help in the management and resolution of uniquerepresentations of master data concepts. For example, the law stipulates the use of

the National Provider Identifier as information that needs to be reported. In turn, the

business terms, data element definitions, master reference concept definitions,

master reference tables and usage mappings can all be centrally managed within a

metadata facility.

Parsing, Standardization and Identity ResolutionThe variety of systems used for tracking the transactions subject to transparency

reporting, as well as the variety of ways that each individual entity may be

represented, poses data quality challenges for resolving uniqueness among

recipients, products, payment classifications and organizational or family hierarchies.We have identified a need for determining whether the item provided to the covered

recipient is one that must be reported, as well as the details regarding the nature of

the transfer of value. Data value classification employs parsing and standardization

along with business rules to normalize data values and map them to the master

reference classification values.


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There is also a need to mitigate the risk of false positive matches and false negative

misses. Costly manual review and scrubbing is neither effective nor sufficient,

suggesting the need for identity resolution tools and techniques. Identity resolution

incorporates data management best practices that can help flag data errors due to

flawed record matching/merging, incomplete internal data entry and inaccuratethird-party submissions. In turn, effective identity resolution tools and techniques will

enhance the ability to recognize relationships across the data sets and lead to

greater trust in the reported data.

Data IntegrationThis is pure and simple: the fact that the data is likely to be sourced from multiple

data sets means that compliance will depend heavily on the ability to extract data

from those sources and integrate the extracted data into the target framework for

data exchange.

Data and Policy GovernanceData quality assessments using data profiling tools and techniques will help in

identifying possible data rules that lead to mitigating the potential risks in accurate

reporting. These rules can be integrated directly into the information production flow

so that potential errors are flagged as early as possible within the business process,

and the appropriate data stewards can be notified. By instituting a best practice such

as operational data governance implemented using data controls, the reporting

organization can provide data auditing and monitoring, perform data validation, as

well as targeting potential data outliers to reduce the risk of not properly complying

with the law.

Ancillary BenefitsWhen considering the data management implications associated with supporting

compliance with the transparency reporting directives, the effort is primarily centered

upon establishing a set of data quality and data management best practices. But as

an added bonus, the institutionalization of these best practices can provide multiple

additional benefits to the organization.

Spend Analysis and ManagementBy collecting the data associated with the different types of transactions representing

a transfer of value, the applicable manufacturer will be able to determine total spend,

over time, for each covered recipient across allpayment systems that exist within theorganization. This may include accounts payable, grants, reimbursements, education

resource management, legal and compliance. The number of internal payment

systems is limited only by the defined natures of transfers of value. Other examples

of spend data capture may include: payable-to vs. recipient for grants, coverage of

expenses for invitees to conventions or healthcare events, and even the cost of light

snacks provided by sales associates.


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A best practice for enabling the collection of this information involves the

institutionalization of a spend analysis program. This will also require the definition

and management of business rules for spend analysis relating to definitions of health

care provider organizations, physician types and specialties, as well as

methodologies for allocating costs associated with the different value transferactivities. In addition, the organization must ensure that they have the proper tools

and capabilities supporting spend analysis, especially with respect to data

warehousing and data organization, along with data classification tools and

techniques. Supporting the reporting requirements also benefits the organization

that can use the same classification and aggregation techniques to help analyze

aggregate spending. This, in turn, can lead to identification of opportunities for cost

reductions, enable better negotiations with suppliers, and oversee organizational

practices for procurement in an auditable way.

Physician Data Insight

The ability to analyze physician data for the purpose of identity resolution creates theopportunity for establishing a unified view of physician data for alternate purposes.

The benefits of improved physician insight include compliance with other

regulations, more efficient grant management, as well as more effective allocation of

marketing budgets. Identifying organizational entity links among sets of physicians

enables better visibility into their relationships, and correspondingly, their own

spheres of knowledge and influence.

Data Management for Physician Transparency: NextSteps

Despite the perception of complexity posed by the reporting requirements of thephysician payment transparency provisions included in the Patient Protection and

Affordable Care Act of 2009, rational next steps can be taken to establish the data

management fundamentals for compliance. By ensuring a level of competency for

data assessment, metadata management and data quality techniques, an

organization can be assured that its data integration, consolidation and data

governance facilities will be sufficient to support reporting compliance. Lastly, these

data governance abilities will enable a deeper level of physician data insight that can

be harnessed to provide many related benefits.

To learn more about data governance, visit:

dataflux.com/knowledgecenter/dg


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Documents

WP069 DM Requirements for Physician Payment Transactions