responding to the call of state reporting v0 · 2010. 5. 19. · by october 1, 2011, procedures...

PwC

Responding to the Call of StateReporting Laws and the NewlyPassed Federal SunshineLegislation

Jennifer Colapietro, DirectorPwC Pharmaceutical and Life Sciences Advisory Service

May 18, 2010

Agenda

• The Evolving Regulatory Landscape• Industry Challenges, Impact and Considerations• Responding to the Call of Aggregate Spend

PricewaterhouseCoopersMay 18, 2010

Slide 3

Changing Regulatory LandscapeFacing New Challenges

Pharmaceutical, Medical Device, Diagnostic, and Biotech manufacturers faceever-increasing pressures related to a changing regulatory landscape aroundTransparency and Aggregate Spend

Increasingly complex and changing regulatory landscape• 8 states have existing disparate legislation setting limits on industry engagement and

payments to customers and/or requiring the disclosure of these payments & costs• More and more states will be passing distinct aggregate spend requirements• Recent passage of federal transparency legislation - Patient Protection and Affordable Care

Act: Section 6002 "Transparency Reports …" (the Sunshine Act provision)• Medical Schools & Institutions are enacting their own disclosure requirements/prohibitions• Enhanced spend disclosure provisions in recent CIAs• Voluntary corporate transparency and disclosure initiatives• Other countries are developing transparency standards


Slide 4

Changing Regulatory LandscapeExpanding provisions, prohibitions and restrictions

• Code of Conduct Laws –requires companies to adopt policies,procedures or marketing codes ofconduct in accordance with industrycodes, state laws, or federalguidance

• Gift Ban/ Limit Laws – limitsand/or prohibits the amount and/ortype of expenditures that can beprovided to health care practitioners

• Disclosure Laws – requirescompanies to annual disclosurecertain expenditures/transfers ofvalues provides to covered recipients

CA DC ME MA MN NV WV VT FederalLaw Type

Code of Conduct X X X X

Gift Ban/ LimitLaws X X X X

Disclosure Laws X X X X X X XApplicability

PharmaceuticalManufacturer X X X X X X X X X

DeviceManufacturer X X X X X


Slide 5

Changing Regulatory LandscapeDisparity in States’ Marketing and Disclosure Laws

DC ME MA MN VT WVApplicability

Pharmaceutical Manufacturers X X X X X XMedical Device Manufacturers X X

Disclosure RequirementsMeals X X X XGifts X X X XTravel X X X X X XHonoraria X X X X X XGrants X X XResearch Payments (Clinical Trial/ProductDevelopment)

X X

Advertising X X XEmployer/ Contractor Cost X X

Reporting ThresholdReporting Threshold $25 $25 $50 $100 $0 $100

Reporting TimelineReporting Deadline 7/1 7/1 7/1 5/1 10/1 4/1


Healthcare Reform Overview

Slide 6

What is commonly referred to as "health reform" is a product of two separateBills:

• Patient Protection and Affordable Care Act (PPACA) – 3/23/10• Health Care & Education Reconciliation Act (amended the PPACA) – 3/30/10

In addition, some health reform changes, were previously implemented through thepassage of the American Recovery and Reinvestment Act (ARRA), also known as the"stimulus bill”

• This is the most substantial change to the US health system since the passage ofMedicare

• Congressional Budget Office estimates that approximately 32 million people will gaincoverage at a cost of $940B over 10 years

• Deficit will be reduced by $138B over the same period• Expanded access will be implemented and paid for through new mandates, fees,

regulatory and reimbursement reform, health exchanges, and new incentives

• All of these will have profound effects on health organizations


“Sunshine Provisions”: Section 6002 "Transparency Reports andReporting of Physician Ownership or Investment Interests“

Provisions Patient Protection & Affordable Care (3.23.10)

Timing Data Collection: January 1, 2012

Report Submission: March 31, 2013

Website Posting: Sept 30, 2013 (and on June 30th of each year thereafter)

Review & Correction Period: Less than or equal to 45 days from date of posted info

Annual reports will be submitted to Congress and bi-annual reports will be provided to each Statewith respect to each State's covered recipients

Covered Recipients • Physician

• Teaching Hospital

Reporting Threshold • Payments >$10, unless exceeding annual aggregate of $100

Transfers of Value Description of transfer of value as:- Consulting fees- Compensation for services other than consulting- Honoraria- Gift- Entertainment- Food- Travel (including the specified destinations)- Education- Research- Charitable contributions- Royalty or license- Current or prospective ownership or investment interest- Direct compensation for serving as faculty or as a speaker for Med Ed program- Grant- Any other nature of payment or other transfer of value (as defined by the Secretary)

Pre-emption • In the case of a payment or other transfer of value provided by an applicable manufacturer thatis received by a covered recipient (as described above) on or after January 1, 2012, theseprovisions shall preempt any state statute or regulation

• No pre-emption of additional state requirements


Provisions Patient Protection & Affordable Care (3.23.10)

Exclusions - Less than $10 until exceeding $100 in aggregate

-Samples* (to be reported on an annual basis separately as part of “6004-Prescription DrugSample Transparency” provision – report aggregated quantity of named drugs samples disbursedto named HCPs; due 4/1/2012)

- Patient Benefit or Use

- In-kind for charity

- Employees

- Discount (rebates)

- Double blinded activities

- Activities not intended to market or promote to covered recipients

Data to be Reported - Recipient's name

- Business Address

- Physician Specialty

- NPI

- Value and Date

- Name of related drug, device, biologic, if available, to the level of specificity available

- A description of form of payment or transfer of value

- Description of the transfer of value

- Affiliation when the covered recipient requests payment to entity/individual on their behalf

By October 1, 2011, procedures will be established for manufacturer submission

Product Research,Development Agreements &Clinical Investigations

Information should be made available to the public after the first of the following dates:

• Date of FDA approval or clearance of the covered drug, device, biologic or supply

• Four calendar years after date of such payment or other transfer of value was made

Penalties Knowingly failing to report: $10,000 - $100,000 ; not to exceed $1,000,000Unknowingly failing to report: Civil money penalty of $1,000 - $10,000 for each payment orother transfer of value not reported; not to exceed $150,000

“Sunshine Provisions”: Section 6002 "Transparency Reports andReporting of Physician Ownership or Investment Interests“


Sample Reporting: Section 6004 "Prescription Drug SampleTransparency"

Slide 9

Although samples are excluded from the Federal Transparency spend disclosurereports, there is a separate section of the legislation which requires that samples betracked and reported to the department of Human Health and Services but not for“value” reporting purposes.

Requires that manufacturers and distributors (those that make distributions by "mail or commoncarrier") report, no later than April 1 each year (beginning in 2012), the following information forthe preceding year :

- Identity and quantity of drug samples requested- Identity and quantity of drug samples distributed during that year

Information should be aggregated by:- Name- Address- Professional designation- Signature of the practitioner making the request, or of any individual who makes or signsfor the request on behalf of the practitioner.

Agenda



Slide 11

Challenges - OperationalCustomer Scope – uniquely identifying and aligning data

Although the federal legislation has narrowed the scope of Covered Recipients, thereis still a need to maintain a broader customer universe for non-exempt state reqs.

Customer profiles should:

• Be consolidated across theorganization

• Be uniquely identifiable

• Contain certain data attributes& key identifiers

• Serve as a cross-reference fordata aggregation andalignment across all datasources

• Be standardized & cleansedto eliminate redundancy &inconsistency

• Align with reported statecovered recipients andidentifiers

CustomerMaster

Individuals Affiliations Institutions

• Healthcare Practitioners (HCPs)

• Physician Medical/Group Practices

• Consumer/Patient Groups

• Hospitals, Clinics, Nursing Homes

• Pharmacists/ Pharmacies/ PBMs

• Health Benefit Plan Administrators

• Medical Schools and Institutions

• Medical/Professional Organizations

• Government Officials

• Third-Parties


Slide 12

The increased scope of transparency is causing companies to assess multiple pointsof interaction

Challenges – OperationalCovered Recipient Interactions – many people internal and external to theorganization interact with the same customers

CoveredRecipient

Managed Markets

Field Sales &Sales Agents

Trade Affairs

Medical AffairsUS HCP

EngagementO-US

Contract Sales& AlliancePartners

Marketing(Direct &

Non-Personal)

Research &Development

Suppliers/Third-Party

VendorsGlobal

Marketing


Slide 13

Challenges - OperationalSpend Types - disparate internal and external information systems

The majority of the data that is required to be reported is either manually captured,is duplicated in multiple systems and needs to be reconciled, and/or is resident insiloed applications or data repositories across the organization

Payment types:• Gifts (including text books and models)• Meals• Entertainment• Honoraria and expenses associated with:

- Speaker Programs- Speaker Training- Advisory Boards- Consulting Agreements- Investigator Meetings- Clinical Consulting

• Grants• Research payments (clinical trials, product

development)• Product sampling• Advertising spend in state• Aggregate employee/contractors

costs associated with adv/promo activities• Ownership or Investment Interests

Required data attributes reside in separatesystems and contracts within:

• Sales• Marketing• Global Marketing• Medical Affairs• Contract Management• Finance (including expense systems)• Legal• Compliance• HR• Research and Development• Third-Party Vendors• Contracted Agents & Alliance Partners• Non-US countries


Slide 14

CustomerMaster

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Monitoring

Disclosure

Cost Reduction

BusinessDecisions

AggregateSpend Insight

Monitoring

Disclosure

Cost Reduction

BusinessDecisions

ComplianceInsights

Sales Marketing MedicalAffairs

R&D Complianceand Ethics

IS

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Engagement of HCP


Speaker Programs/Consulting Agreements


Grants and Contributions


Meals and Educational Items


Other ….

How Do You Connect These Pieces Together?

CustomerMaster

VendorMaster

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Finance

Application Landscape

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Monitoring

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BusinessDecisions


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BusinessDecisions

ComplianceInsights

Monitoring

Disclosure

Cost Reduction

BusinessDecisions


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Disclosure

Cost Reduction

BusinessDecisions

ComplianceInsights



IS


Speaker Programs


Consulting Agreements






Other ….


CustomerMaster

VendorMaster

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Finance


Challenges - OperationalArchitecting an integrated, scalable and sustainable solution


Challenges - OperationalCompanies are going to need to make some tough strategic decisions aboutcontinuing certain existing business activities and programs given theevaluation of risk and level of effort

• Are there certain promotional activities that no longer make sense to continue engaging inwith customers?

• Should one or both parties in an Alliance Agreement (such as a JV) be required to report?

• Do we want to continue sponsoring U.S. HCPs to speak or participate in conferences andmeetings outside the U.S.? Do we want to continue allowing non-US countries to sponsorU.S. HCPs to speak or participate in conferences and meetings in the U.S.? What processesmay need to change?

• Can we consolidate the number of third-party vendors used across the organization formeetings, events, and logistics?

• Will we allow our primary third-party vendors to subcontract with secondary vendors? Will weallow them to continue to utilize their own solutions for reporting and/or establish standardsrelative to their data reporting requirements and format?

• Given the challenges associated with aggregating ex-U.S. customer data – privacy laws,language differences, conversion factors, lack of financial shared services or systemscentralization – what should our “global” strategy be?

Slide 15


Slide 16

Challenges - OperationalStrategic Decisions, New/Revised Policies, Processes and Org Support

• Defining the Universe (scope of activities to report, assign $ value, caps)

• Maintaining business rules for allocation, aggregation, inclusion & exclusion

• Internal and External Communications (Inbound and Outbound)

• Response and Escalation Protocols

• Handling Reporting Corrections and Potential Violations

• Data Validation, Reconciliation, & Report Certification Procedures

• Monitoring and Auditing

• Transparency Governance (corporate and divisional)

• Third-party and business partner contract language

• Impact of federal and states data privacy and information protection laws

• Business Intelligence (Metrics/KPIs)

Agenda



Slide 18

PwC’s MethodologyOur Approach for Aggregate Spend

1. VisionConduct a current state assessment toidentify gaps and priorities. Develop aphased enterprise-wide vision andstrategy for Transparency/Aggregate Spend

2. EnablementEnable an integrated view of spendby standardizing processes, establishingenterprise-wide master data management,consistently capturing spend at the point ofengagement and implementingscalable/flexible solutions

3. DeliveryDeliver the ability to easilyconsolidate, analyze and proactivelymonitor aggregate spend and reportinternally and externally. Drive businessvalue with actionable insights & metrics


Transparency & Aggregate Spend Approach:Develop an Enterprise-wide Vision and Strategy

Strategy & Objectives• Identify channels for engaging customers• Identify key stakeholders & information needs• Determine scope of aggregate spend• Create an inventory and establish common definitionsof customer and spend activity types

Conduct Current State Assessment & DefineFuture State VisionIdentify issues and improvement opportunities:- Policies and business processes- Data architecture and integration- Front-end applications and enabling technology- People, communication, & training- Proactive monitoring, reporting and analytics- Regulatory compliance

Future State Roadmap• Conduct gap analysis of current/future state• Prioritize needs & opportunities• Develop phased roadmap of initiatives• Identify costs & benefits (business case)

Slide 19


Transparency & Aggregate Spend Approach:Enable Integrated Vision and Strategy

Process Standardization & Integration• Policy and Process Alignment• Streamline, standardize, and automate• Embed compliance & monitoring controls• Incidence management and remediation

Information Supply Chain Enhancement• Establish a clear data strategy (how, when &where data is captured & integrated)• Enterprise-wide Master data management(e.g., Customer and Product)• Data integration & business intelligence• Incorporate governance, privacy & securityconsiderations

Cultural Alignment• Organizational roles & responsibilities• Open communication and collaboration• Ongoing training and education• Enforcement and discipline

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BusinessDecisions


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Disclosure

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BusinessDecisions

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Engagement of HCP




Other ….


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Cost Reduction

BusinessDecisions

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Engagement of HCP




Other ….


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Slide 20


Transparency & Aggregate Spend Approach:Deliver the ability to consolidate, analyze & proactively monitor

Information Delivery to keystakeholders (internal & external)• Standard reporting & KeyPerformance Indicators• Predictive analytics• Proactive monitoring (detectiveand preventative)• Delivery of key information tostakeholders• Continuous information exchange

Benefits Realization• Detect and report issues, andconflicts of interest• Prevent and mitigate risks• Further drive business value andinsight• Improve decision making

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Slide 21

PwC

www.pwc.com

Jennifer A. Colapietro, DirectorPricewaterhouseCoopers LLP

Pharmaceutical & Medical Device Advisory(973) 236- 4124

[email protected]

© 2010 PricewaterhouseCoopers LLP. All rights reserved. "PricewaterhouseCoopers" refers toPricewaterhouseCoopers LLP (a Delaware limited liability partnership) or, as the context requires, othermember firms of PricewaterhouseCoopers International Ltd., each of which is a separate andindependent legal entity. *connectedthinking is a trademark of PricewaterhouseCoopers LLP.

responding to the call of state reporting v0 · 2010. 5. 19. · by october 1, 2011, procedures...

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