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Health Analytics
Driving insights and solutions in disputes, investigations, and risk management.
Who We Are
Data driven, objective, and innovative.
BRG’s Health Analytics practice provides clients with extensive healthcare industry expertise combined with data-driven, objective, and innovative solutions to their most complex problems.
Our professionals have backgrounds in healthcare economics, information technology, management and administration, finance, accounting, government regulation and enforcement, and academia. Many have relevant advanced degrees and certifications including PhDs, MBAs, CPAs, CFEs, and coding certifications.
Our experts have decades of experience and specialize in areas such as healthcare policy, finance, reimbursement, operations, regulatory compliance, and health data and data management, as well as investigations, litigation, and dispute resolution.
Our Mission
We help solve our healthcare clients’ most complex challenges with real-world industry expertise, advanced analytics, and actionable insights.
Our Vision
To be the most innovative healthcare consulting practice, driven by shared ownership, talent advancement, and industry-leading intellect and analytics.
What We Do
A core strength of our practice is our ability to harness and unlock the power of the information generated in the healthcare system. We regularly leverage financial, clinical, operations, and survey data maintained by payers, providers, manufacturers, and government entities to develop solutions to our clients’ most pressing issues.
Discover How We Can Help
Please answer the following questions so we can help you find the right expertise to address the issues facing your business.
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What is your business need?
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You selected
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Experience
- Qui tam and government litigation
- Cases involving medical necessity, provider practice patterns, and technology
- Matters related to provider coding, billing, and reimbursement
- Disputes involving issues with cost reporting
- Securities fraud–related matters for publicly traded provider organizations
- Matters alleging lack of proper controls related to quality measures
Engagement Examples
- A BRG expert was retained by counsel for a hospital to provide independent analysis and expert testimony for a class action case related to the reasonableness of hospital charges. The BRG team reviewed a previously submitted expert report that responded to a court order to present a “class-wide damages methodology” and to propose a definition of “substantial” payment for class notice purposes. During the course of the engagement, the BRG team evaluated the appropriateness of the “class-wide damages methodology” proposed by the other expert using hospital cost reports and industry standards to determine what reasonable hospital charges should have been.
- A BRG expert was engaged by the holding company for a large for-profit health system being sued by shareholders for securities fraud. Specifically, BRG was asked to investigate the cause of a major drop in earnings and to determine if the company could have known about this decrease before it happened. This decrease led to a drop in the company’s stock price shortly after the company went public. BRG conducted a number of financial and market analyses and investigated possible reasons for the decrease, using the company’s monthly financial reports and claims data. Our team built a comprehensive model to understand the potential causes of the hospital system’s performance. This model was used throughout the case to understand how the performance tracked to expectations provided to investors. This model refuted the claims offered by the plaintiffs and had a material impact in reducing the settlement value.
- A BRG team member served as the expert witness in a case that involved a dispute over monies allegedly not paid by an insurer for care rendered. Our expert provided testimony on the reasonableness of charges submitted by the hospital. Our team of experts used publicly available data to benchmark charges per discharge by Diagnosis Related Group and per outpatient procedure. We also utilized cost report data to benchmark the hospital’s performance against peer facilities.
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Experience
- Government and internal investigations related to:
- Medical necessity issues
- Provider practice patterns
- Reimbursement, including billing and coding
- Cost reporting
- Use of healthcare technology, including electronic health records
- Sampling and extrapolation in the context of medical records and medical necessity reviews
- Presentations to investigating agencies
Engagement Examples
- BRG experts supported a regional medical center that was the subject of a False Claims Act (FCA) investigation regarding the medical necessity of a specific procedure code. The team created a model that categorized each claim as medically necessary or not medically necessary and calculated the related impact to reimbursement.
- BRG experts supported a large hospital that was the subject of a Department of Justice investigation and was in the process of conducting several internal investigations. We used BRG’s data warehouse of Medicare claims to analyze the hospital and physician practice patterns. We compared the metrics for the hospital with other hospitals throughout the US. Our team developed a sampling methodology and supported a clinical review to determine if medical necessity issues existed.
- A BRG team was hired to analyze data from an electronic health records (EHR) system as part of an FCA investigation of a home health agency (HHA). The team analyzed EHR data to understand if changes were being made in the system that impacted reimbursement or quality metrics and sought to quantify whether these changes had a financial impact on the HHA.
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as your business need.
Experience
- Compliance program assessments
- Compliance effectiveness assessments
- Enterprise risk assessments
- HCC coding reviews
- Private equity due diligence reviews, including coding and compliance operational assessments
- Inpatient, outpatient, and professional fee coding, billing, and documentation compliance
- Independent review organization services
- Interim compliance staffing
Engagement Examples
- BRG experts have performed compliance program and risk assessments, compliance effectiveness assessments, and compliance program implementations for hospitals, health systems, and large physician practices. Our experts have served in various compliance and revenue cycle capacities at many of the nation’s top academic medical centers.
- A BRG expert, prior to joining the firm, was retained by the Board of Managers (Board) of a leading public safety net health and hospital system as its independent governance and healthcare compliance advisor. The expert issued two comprehensive reports that the Board released to the public. The first addressed the Board’s fiduciary duties and oversight obligations with respect to quality of care, patient safety, and regulatory compliance. The second focused on corporate governance, cultural transformation, and restoration of trust with key stakeholders. The reports included observations and comprehensive recommendations regarding the Board’s responsibilities; the size and composition of the Board; the appointment process; and Board operations, including its annual self-assessment. The Board implemented the key recommendations, several of which required legislative amendments.
- BRG has served as the Independent Review Organization (IRO) for clients under multiyear Corporate Integrity Agreements (CIAs) with the Office of Inspector General, US Department of Health and Human Services. As an IRO, BRG evaluates current compliance programs and makes recommendations to fill existing gaps and bring programs into adherence with the Office of Inspector General compliance program guidance. BRG also plans and performs audits to assess coding and billing accuracy and works in tandem with government monitors to successfully meet the requirements of each individual CIA.
- A BRG expert, over a period of several years prior to joining the firm, advised a leading provider of kidney dialysis services on the implementation of obligations under a CIA with the Office of Inspector General, US Department of Health and Human Services. The expert worked closely with the chief compliance officer, in-house compliance and legal teams, and client’s outside counsel to operationalize the requirements. He also assisted the compliance team with the preparation of the implementation and annual reports mandated by the CIA.
- BRG experts have evaluated over sixty potential investments in the provider sector by private equity firms. Our work has involved a robust analysis of the provider’s practice patterns using Medicare claims data in conjunction with a clinic documentation/coding review. Additionally, BRG evaluates compliance programs of investment targets to determine gaps and risk areas in need of attention post acquisition.
- BRG’s coding auditors have completed MS-DRG, APR-DRG, OPPS, and professional fee coding reviews to assess coding accuracy.
- BRG’s coding auditors have completed hierarchical condition category (HCC) coding reviews and encounter-specific coding and documentation reviews to assess risk score accuracy and documentation completeness.
- BRG experts have completed coding compliance and operational assessments for physician groups. The assessments have included the review all operational components related to coding and documentation, identification of areas of improvement or high levels of regulatory compliance risk, and insights on beneficial changes and risk mitigation.
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as your business need.
Experience
- M&A transactional advisory, due diligence, corporate valuation, and transactional opinions (capital adequacy, fairness opinions, solvency opinions)
- Financial advisory, quality of earnings analysis, feasibility studies, debt capacity and structuring, Certificate of Need assistance, regulatory change, reimbursement analysis, structure evaluation (e.g., Accountable Care Organization formation), bankruptcy, physician integration
- Quality and value-based reimbursement assessment and analytics
- Case mix and revenue integrity analytics
- Healthcare information technology (HIT) optimization
- Direct Contracting Model strategic alignment services
- Value-based care advisory services
- Outpatient advisory services
- Hospital performance improvement
Engagement Examples
- BRG experts were engaged by three regional health systems in Maryland to assess the prospective benefits of collaboration including financial efficiencies, clinical integration, and population health strategy. Work product included proposals for five alternative affiliation models with varying levels of provider and management integration.
- BRG experts jointly facilitated a merger of two health systems, including developing a plan to convert one acute-care hospital to a free-standing medical facility (closing inpatient and surgical services) and taking the transaction through regulatory approvals and closing.
- BRG experts were retained by several dialysis providers to analyze the financial impact of ballot initiatives in California. Our team of experts conducted financial modeling that was then presented to a state agency.
- BRG experts have been retained as subject-matter experts for quality and value-based reimbursement consulting by a variety of provider entities.
- A BRG expert was engaged by the board and senior staff of a hospital that was part of a large health system to design and report key performance indicators and provide education related to quality and value-based reimbursement.
- A BRG expert is currently working with provider groups to support value based operational setup and was engaged by provider groups to help improve the operational efficiency of the office setting and measure the quality of care for patients. The engagements included creating visibility and tracking processes for value-based care arrangements that assisted in oversight and improvement for contractual language, quality measures associated with Star Ratings and HEDIS, and risk adjustment.
- A BRG expert was engaged by a large provider group to assist it with understanding and preparing for operational changes around the Direct Contracting Model with the Centers for Medicare and Medicaid Services.
You selected
as your sector and
as your business need.
Experience
- Provider and payer in- and out-of-network reimbursement disputes
- Breach of network agreements/member tampering
- Breach of employment agreements
- Provider directory and network adequacy litigation
- Class action litigation
- Antitrust litigation
- Qui tam and government litigation
- Litigation involving use of healthcare technology
Engagement Examples
- BRG experts have been retained by outside counsel for payers in connection with reimbursement disputes with providers for both in- and out-of-network services. BRG experts have analyzed issues related to the interpretation and application of contractual clauses, appropriateness of denials, Medicare sequestration withholds, and fair market value rates for out-of-network provider services.
- BRG experts have been retained in matters related to alleged breaches of network agreements and claims for lost profits from alleged inappropriate conversions of physicians from one provider group to another, allegedly resulting in lost capitation revenue and profit from the original provider group.
- BRG experts have been retained in class action matters involving payers to analyze class certification, including evaluating the attributes of both the named plaintiffs and proposed class members.
- BRG experts were retained by counsel for a health plan being sued by a hospital system for alleged antitrust violations related to a failed merger. The BRG experts offered independent opinions and conclusions on behalf of the health plan.
You selected
as your sector and
as your business need.
Experience
- False Claims Act investigations
- Billing and coding investigations
- Risk adjustment diagnosis coding and data submissions
- Reimbursement issues
- Compliance violations
- Delegated entity oversight
- Fraud, Waste, and Abuse (FWA) hotline and whistleblower investigations
- Self-disclosures
Engagement Examples
- BRG professionals have been retained by counsel for Medicare Advantage organizations (MAOs) to provide services related to government investigations into their risk adjustment programs. BRG experts have assisted with fact development, data analysis, retrospective and prospective chart reviews, diagnosis code validation, and strategic defense consulting.
- BRG professionals have been retained to assist with investigating alleged compliance violations by health plans or their delegated entities. Issues have included, for example, alleged failure to meet timeliness standards, inappropriate denial of care and manipulation of reported denial rates, concurrent review and retrospective review processes, and failure to address quality-of-care issues.
- BRG professionals were retained in a criminal investigation of and subsequent litigation against health plan executives who allegedly reported inflated plan expenditures for plan enrollees to increase medical loss ratio calculations. BRG professionals helped with discovery, case strategy, data analysis, and deposition and trial preparation.
You selected
as your sector and
as your business need.
Experience
- Comprehensive compliance program assessments
- CMS regulatory compliance assessments
- Risk adjustment compliance assessments
- Risk adjustment data validation (RADV) audit support
- Medical Loss Ratio reporting compliance
- Payer and delegated entity regulatory audits
- Independent review organization (IRO)/monitor/validator/conservator
Engagement Examples
- BRG professionals have been retained by outside counsel for multiple Medicare Advantage organizations (MAOs) and private equity firms to perform operational and compliance assessments of the MAOs’ risk adjustment programs and operations.
- BRG professionals have developed statistical analyses of diagnosis codes submitted by network providers in compliance-focused efforts to help identify potential outlier providers that may be submitting inaccurate or unsupported diagnoses.
- A BRG expert, prior to joining the firm, was retained to serve as the interim chief compliance officer by the managed care division of a global health service company operating under sanctions imposed by the Centers for Medicare & Medicaid Services (CMS). The client had an acute need to accelerate the development of its compliance and ethics programs while recruiting permanent leadership. The expert provided essential on-site expertise and led the executive searches.
- BRG professionals have assisted MAOs with reviewing medical charts submitted to CMS and Office of Inspector General, US Department of Health and Human Services in RADV audits to identify documented support for diagnoses submissions and help prepare appeal responses.
- A BRG professional was appointed by a state Attorney General’s office to serve as the independent monitor of a settlement related to reported inaccuracies in a health plan’s online provider directory.
- BRG professionals have served as the independent monitor on behalf of the California Department of Managed Health Care and multiple health plans to develop and implement corrective action plans (CAPs) to restore financial stability and compliance with regulatory requirements.
You selected
as your sector and
as your business need.
Experience
- Reimbursement advisory, including fee schedule development and recalibration, prospective payment feasibility and implementation, benchmarking, bundled payment development, and out-of-network policy review
- Performance improvement and turnaround
- Network adequacy and provider directory accuracy
- Medicare Advantage and Affordable Care Act strategic executive-level planning sessions focused on policy change impacts
- Operational improvements and efficiencies
- Risk adjustment and quality measure process improvements
- Vendor selection and monitoring support
Engagement Examples
- BRG professionals have been retained by member plans of a national health insurance association to advise on reimbursement strategy. This includes reimbursement for providers across the spectrum, including professional, inpatient, and outpatient. BRG experts have developed/rebased reimbursement methodologies and participated in contract negotiations.
- A BRG professional has been working with a health plan for nearly a decade to monitor, evaluate, and periodically update the plan’s reimbursement approaches and rates for all provider types.
- BRG professionals worked with a regional health plan in California to evaluate and update its out-of-network reimbursement approaches and rates and develop a reasonable and customary policy to comply with Department of Managed Health Care requirements.
- A BRG professional has conducted strategic strategy sessions with health plan executives around policy impact changes. The sessions conducted with C-suite and board-level executives were designed to structure future growth opportunities.
- A BRG professional has worked with health plans to understand current state functionality to assist with restructuring and aligning more efficient processes for all operational functions, inclusive of enrollment, membership and claims processing, care management, quality measures, risk adjustment, and enterprise data warehouse.
You selected
as your sector and
as your business need.
Experience
- Government price calculations (AMP (Average Manufacturer Price), BP (Best Price), ASP (Average Sales Price), etc.)
- Sales and marketing issues (off-label, healthcare provider compensation, consumer protection, etc.)
- Intellectual property
- Product liability
- Antitrust and price fixing
- Hatch-Waxman issues and reverse payments
- Valuation and market analyses
- Licensing and royalty rate calculations
- Financial projections and impact analyses
- Contract disputes/contractual performance
Engagement Examples
- A BRG expert analyzed relator’s expert’s report in a qui tam matter alleging the branded manufacturer defendant underpaid Medicaid rebates due to its improper treatment of inventory management fees and price appreciation credits in the calculation of AMP. The BRG team identified logical and mathematical errors in the relator’s damages calculation and accounted for increased government payments under other programs under the relator’s theory that offset damages.
- BRG experts have been retained, separately, by an opioid manufacturer and a national distributor facing claims of product liability, false advertising, failure to comply with the Controlled Substances Act, negligence, and nuisance brought by classes of consumers, providers, municipalities, and other plaintiffs in the nationwide opioid multi-district litigation and similar state cases. BRG experts have submitted expert reports on industry topics and claims for economic damages. They have analyzed terabytes of pharmaceutical sales, chargebacks, prescriptions, claims, and reimbursement data spanning two decades and multiple company systems.
You selected
as your sector and
as your business need.
Experience
- Federal Trade Commission, Securities and Exchange Commission, Department of Justice (DOJ) False Claims Act and Anti-Kickback Statute investigations
- Government price reporting (AMP (Average Manufacturer Price), BP (Best Price), ASP (Average Sales Price), etc.)
- Sales and marketing issues (off label, health care provider (HCP) compensation, consumer protection, etc.)
- Medicare Part D issues
- Coverage determinations
- Prescription Drug Event submissions/reporting
- Direct and Indirect Remuneration and rebate issues
- Reimbursement and copay coupons
- Charitable copay foundation investigations
- Presentations to investigating agencies such as Office of Inspector General, Centers for Medicare and Medicaid Services, and DOJ
Engagement Examples
- BRG experts were retained by outside counsel for a medical device manufacturer accused by the Civil and Criminal divisions of the DOJ of using HCP speaker fees, consulting fees, travel expenses, and in-kind product as kickbacks to induce use of the company’s products. The BRG team mined the company’s current and legacy accounts payable systems to identify potential remunerations to HCPs to evaluate issues of liability and analyze potential exposure estimates based on Medicare and Medicaid reimbursements.
- BRG experts have been retained by pharmaceutical manufacturer clients related to investigations being conducted by a US Attorney’s Office related to certain aspects of private copay assistance foundations. We have developed detailed analyses to examine whether correlations exist between manufacturer donations and foundation assistance payments, created financial models to determine the amount borne by the government related to Medicare claims partly paid for by foundation assistance, and analyzed programs related to the impact of copayment assistance on plan benefit designs/patient out-of-pocket requirements.
You selected
as your sector and
as your business need.
Experience
- Compliance program development and effectiveness assessments
- Serve as IRO (Independent Review Organization) and provide pre-IRO compliance and readiness assessments in connection with Deferred Prosecution Agreements and Corporate Integrity Agreements
- Risk assessments and mitigation plans
- Distributor and third-party risk management
- Global anti-bribery/anti-corruption
- Fraud detection and prevention
- Advanced data analytics/forensic reviews
- Government price reporting
- Bona fide service fees
- State price transparency
- Fraud and compliance training development
Engagement Examples
- BRG professionals conducted a compliance risk and monitoring assessment for a multinational medical device company operating in over seventy-five global jurisdictions. The assessment included: a comprehensive anti-bribery and corruption risk assessment; policies and procedures review; analysis of public tenders with governmental entities focused in “high-risk” markets, third-party payment analysis, sales and expense data, the company’s ledgers, and agent/consultant contracts to recreate financial transactions; and an assessment of the company’s payment control environment.
- A BRG expert, prior to joining the firm, was retained by the Nominating, Compliance, and Governance Committee of the Board of Directors of a global medical device company operating under a federal Deferred Prosecution Agreement (DPA) and Corporate Integrity Agreement (CIA). Problematic conduct had been disclosed to the corporate monitor, as well as to regulators and enforcement agencies, and the expert was retained to assess the effectiveness of the company’s compliance and ethics program. The expedited review culminated in a set of recommendations that were discussed with the monitor and government officials, and the recommendations were implemented quickly. The term of the DPA and monitorship was extended for an additional year, but no other enforcement actions were initiated.
- BRG professionals developed and implemented a comprehensive anti-corruption and anti-bribery program on behalf of a large global medical device company, which included procedures for screening and monitoring existing third-party vendors overseas, as well as an onboarding process for new third parties. As part of this engagement, the BRG team screened over ninety third-party distributors in more than forty countries.
- Prior to joining the firm, BRG professionals conducted a government price reporting compliance assessment, including the review of government program policies, data collection, systems, and reporting submissions. This assessment included parallel government pricing calculations for all price types (e.g., AMP, BP, 340B, ASP, NFAMP) to ensure policy was aligned to what was reported to each of the relevant government agencies. As part of this engagement, the BRG professionals identified potential compliance risks and made recommendations to senior management to mitigate those risks moving forward.
- BRG professionals performed a systematic review of the compliance policies, procedures, and supporting financial systems for a specialty pharmacy after acquisition by new ownership. The BRG team’s report to the board resulted in various systemwide improvement initiatives.
- A BRG expert, prior to joining the firm, advised a leading global biotechnology company on the negotiation and implementation of a CIA with the Office of Inspector General, US Department of Health and Human Services. The expert was retained through the client’s outside counsel and collaborated closely with the in-house compliance and legal teams to develop the negotiation strategy, assessing the feasibility of key commitments and ensuring that the client was prepared to fulfill them.
You selected
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as your business need.
Experience
- 340B compliance and monitoring, including duplicate discount recoveries
- 340B finance, contract operations, and gross-to-net calculations
- Federal and state policy analysis
- Strategic and operational consulting and pharmacy director surveys
- Government pricing calculation methodology (e.g., AMP, BP, ASP, 340B, NFAMP, FCP) and reasonable assumption evaluation, development, and implementation
- Government program operational assessments
- Government pricing strategic support and system/managed service evaluation and implementation
- Government program (Medicaid, Medicare, VA/FSS, 340B) forecasting and scenario planning
- Support for brand forecasting and salesforce targeting and education
- Financial projections/budgeting
- Transaction valuation opinions
- State price transparency strategic support and system evaluation and implementation
Engagement Examples
- BRG professionals have developed a suite of tools that help address both discrete issues and broader strategic questions that manufacturers face in the 340B channel. The BRG team provides actionable data, policy analysis, software solutions, and operational strategy for a variety of 340B-related issues for most of the largest pharmaceutical manufacturers in the world.
- A BRG professional helped revamp a Fortune 500 biopharma company’s gross-to-net forecasting for the 340B channel to provide better insight into what factors are driving growth.
- BRG professionals developed an analytical framework to assess a pharmaceutical company’s Loss of Exclusivity portfolio and identify opportunities for increased revenue under Supplemental Rebate Agreement arrangements with State Medicaid programs in exchange for placement on the program’s preferred drug list.
- A BRG expert provided valuation advisory and diligence services in connection with the transaction on behalf of a biopharmaceutical company listed on the Tokyo Stock Exchange Mothers market.
- Prior to joining the firm, BRG professionals reviewed new government program regulations in light of the compliance, operational, and financial impacts they could have on a pharmaceutical manufacturer. The BRG professionals assisted with educating the manufacturer on the new requirements, provided recommendations, and assisted with implementing those recommendations into its ongoing operations.
- BRG professionals performed government program forecasting, over a five-year period prior to joining the firm, for a pharmaceutical manufacturer. Specifically, BRG professionals modeled the financial impact that upcoming changes, including market dynamics, government pricing values, and new government regulations could have on its business. As part of this engagement, the BRG professionals provided pricing and contracting considerations to help mitigate potential financial exposure.
You selected
as your sector and
as your business need.
Experience
- Advanced data analytics and modeling
- Financial, statistical, and econometric analyses
- Liability analysis, damages analysis, and expert testimony
- Operational reviews (prescription processing, prior authorization, performance guarantees)
- Payment, billing, and reimbursement analyses
- Rebate calculation analyses
- Regulatory standards adherence reviews
- Bid protest analysis and support
- Contract dispute and audit resolution services
Engagement Examples
- Counsel for pharmacy benefit managers (PBMs) have retained BRG professionals related to client allegations of breach of contract, overcharges, and damages. The BRG team efficiently analyzes the pharmacy claims data at issue to assess allegations as compared to the governing contracts, respond to expert reports, and issue data-driven opinions in the context of arbitration, mediation, litigation, and settlement.
- BRG professionals have assisted counsel by performing data analytics and providing subject-matter expertise throughout the course of litigation and trial for matters involving antitrust and breach of contract allegations brought by pharmacies related to reimbursement and network status. To help analyze allegations in these matters, the BRG team evaluates pharmacy operations including dispensing activity and data from multiple systems, such as submitted claims, accounts receivable, and billing data. The results of BRG’s analyses are used to support expert reports, critique the opposing party’s expert reports, and provide examples of noncompliance with contract terms at trial, among others.
- Counsel for PBM and pharmacy clients have retained BRG professionals to provide analysis and expert testimony in qui tam matters with False Claims Act and Anti-Kickback Statute allegations related to Medicare Part D, Medicare Part B, Medicaid, and the Federal Employee Health Benefits Program. Using subject-matter expertise combined with advanced data analytics, BRG experts have developed clear and powerful analyses related to allegations and provided consultation throughout the investigation and litigation lifecycle, including discovery, analysis, depositions, expert witness reports and testimony, and settlement.
You selected
as your sector and
as your business need.
Experience
- Advanced data analytics and modeling
- Financial, statistical, and econometric analyses
- Data systems and process review; transaction analysis
- Operational reviews (prescription processing, prior authorization, performance guarantees)
- Payment, billing, and reimbursement analyses
- Rebate calculation analyses
- Regulatory standards adherence reviews
Engagement Examples
- BRG professionals have been retained by pharmacies facing audits or investigations by the US Department of Justice and state Attorneys General. These matters have included allegations and issues such as dispensation and accurate documentation related to controlled substances, lack of prescriber IDs and signatures on prescriptions, dispensation of unnecessary medications, incorrect amounts dispensed and/or invoiced, and improper billing of Medicaid and other third parties. BRG’s role on these matters has included review of pharmacy operations, claims data, redetermination of claims, critique of sampling and extrapolation methodologies, and calculation of alternative potential exposure amounts.
- Counsel for mail order and specialty pharmacies have retained BRG professionals for support during government investigations related to the federal False Claims Act and Anti-Kickback Statute. Issues have included alleged steering of patients to certain drug products in exchange for disguised remuneration, patient referrals from manufacturers, pharmacy practice issues, and alleged overbilling and contractual violations. The BRG team has analyzed millions of prescription, shipment, and invoice data transactions to evaluate pharmacy practice, billing, and reimbursement patterns. For example, we have analyzed comprehensive transactional data sets to identify trends and correlations between pharmacy activities and payments or referrals.BRG professionals also have analyzed millions of patient chart note records, clinical pharmacist notes, and call recordings between pharmacy employees and patients to assess the validity of government allegations. We have used sampling procedures to develop exemplar data and to review fact patterns and helped develop liability and damages analyses related to government theories or allegations. For many of these analyses, a key to our work was the ability to efficiently identify, assimilate, and analyze data from numerous disparate systems. In addition to our ability to analyze pharmacy data, our detailed understanding of Medicaid and Medicare reimbursement for all manner of pharmacy claims has been a key component of our data analytics.
You selected
as your sector and
as your business need.
Experience
- Pharmacy inspection, process review, audit preparation
- Prescription filling, billing, dispensing, claims adjudication (retail and mail order pharmacies)
- Returned goods policies
- Pharmacy product selection and substitution rules
- Fraud, waste, and abuse
- Controlled substances
- OSHA Bloodborne Pathogens standards
- Immunization programs and requirements
- Organizational review of current medication safety practices
- Assessment of policies and procedures to ensure compliance with state and federal regulations
- Pedigree assessments
- 340B compliance reviews
- Pharmacy services agreements
Engagement Examples
- BRG professionals have performed compliance audits and inspections for retail, hospital, long-term care, specialty, 340B, and mail order pharmacies. Our audit teams work with pharmacy personnel to identify potential areas of weakness, prepare a gap analysis and corrective recommendations, assist in corrective actions, and perform reinspection to confirm adoption and execution.
- BRG professionals routinely perform systematic reviews of compliance policies, procedures, and supporting financial systems for pharmacies before and after acquisition by new ownership. Our reports provide stakeholders with better insight into risks and often result in operational improvements.
You selected
as your sector and
as your business need.
Experience
- Pharmacy due diligence and valuation
- Operations, business strategy, and market opportunities
- Prescription benefit plan audits (prescription claims and rebates)
- Marketing strategy for cash or third-party payers
- Medicaid issues
- Contract reviews
- Licensure and sanction issues
Engagement Examples
- BRG professionals have assisted potential buyers and investors with transactions through due diligence reviews and improving operational performance of both retail and mail order pharmacies.
- Private equity firms routinely engage BRG professionals to evaluate regulatory compliance and operational performance of pharmacies, including retail, mail order, long-term care, specialty, and infusion care pharmacies. BRG experts perform an in-depth analysis of day-to-day operations, sourcing, billing, and dispensing practices and provide investors with a comprehensive view of pharmacy operations and areas of strengths and weaknesses as part of the due diligence process.
- A pharmacy benefit manager (PBM) engaged BRG professionals to conduct a study of pharmacy fees as defined by a state statute and to prepare a report of findings. In preparing this study, BRG obtained and analyzed pharmacy claims data, performed outlier analysis to create an analysis data set, and calculated the statistical parameters specified in the statute.
- A skilled nursing and long-term care facility engaged BRG professionals to provide data analytics and modeling support during the bid and evaluation of proposals for drug wholesalers. BRG created a pricing evaluation model that allowed the client to monitor compliance under its existing drug purchase agreement and identify areas where additional discounting could be obtained. The model also allowed for the wholesaler bids to be evaluated and supported the negotiation process with the wholesalers.
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as your sector and
as your business need.
Experience
- Privileged consulting and expert testimony
- Damages modeling
- Corporate Integrity Agreement (CIA) negotiation and implementation
- Technological evidence production and case impact assessment
- Software development life cycle (SDLC) assessment
- Forensic technology assessments and source code review
- Department of Justice (DOJ) Civil Investigative Demand (CID) response
- Office of the National Coordinator for Health Information Technology’s (ONC) Certified EHR Technology (CEHRT)
Engagement Examples
- BRG experts were engaged by a healthcare payer to evaluate allegations that a proprietary electronic health record (EHR) system design and implementation inflated the severity of the clinical condition of patients, resulting in fraudulent coding and billing practices. BRG conducted an independent technological assessment of the EHR system to validate regulatory nonconformance and documentation and coding noncompliance.
- BRG experts were engaged by an EHR developer to develop damages models that quantified the risk of financial exposure due to its customers’ inability to calculate and report automated measures and clinical quality measures in accordance with the 2014 and 2015 editions of the ONC CEHRT and Promoting Interoperability (PI) programs. BRG experts completed a program analysis for Medicaid PI and Merit-based Incentive Payment System (MIPS) and developed industry-specific models that incorporated unique considerations given to individual EHR customers for each program.
You selected
as your sector and
as your business need.
Experience
- Privileged consulting and expert testimony
- Department of Justice (DOJ) Civil Investigative Demand (CID) response
- Office of the National Coordinator for Health Information Technology’s (ONC) Certified EHR Technology (CEHRT)
- Complex technological inquiries and source code review
- Damages modeling
- Corporate integrity agreement (CIA) negotiation and implementation
Engagement Examples
- BRG experts provided confidential consulting services for an ambulatory electronic health record (EHR) developer responding to a DOJ Civil Investigative Demand for allegedly causing false claims to be submitted to the Centers for Medicare & Medicaid Services (CMS) for federal and state incentive payments through the EHR Incentive Program. BRG performed an independent investigation that enabled the translation and interpretation of complex technical inquiries and prepared disclosures. BRG utilized its findings to collaborate on strategies to mitigate risk and liability to the EHR developer. BRG experts also provided strategic consulting regarding the delivery of communications with the DOJ and ONC, including negotiating CIA terms.
- In connection with DOJ settlement negotiations, BRG experts developed data-driven, regulatory fact-based models, which were accepted by the DOJ as revised liability calculations, reducing the client’s exposure by more than 75 percent.
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Experience
- Regulatory agency advisory and strategy: Health and Human Services (HHS), Office of the National Coordinator for Health Information Technology (ONC), Centers for Medicare and Medicaid Services (CMS), and ONC-Authorized Certification Bodies (ONC-ACB)
- Software Development Life Cycle (SDLC) corporate advisory and restructuring
- SDLC compliance and fitness assessments
- Corporate Integrity Agreement (CIA) implementation and compliance
- Regulatory liability exposure modeling
- Market vulnerabilities analysis
Engagement Examples
- BRG professionals conducted a compliance audit of an EHR developer’s SDLC to analyze compliance with best practices and identify potential risk areas as a proactive mitigation strategy during Department of Justice (DOJ) settlement negotiations. BRG experts evaluated leadership fitness, organizational structure, ONC Certified EHR Technology development and implementation processes, and corporate policies and procedures. BRG delivered formal risk mitigation recommendations inclusive of corrective action planning and execution.
- BRG professionals have been engaged by private equity firms to perform buy-side due diligence risk assessments. During these matters, BRG experts have provided qualitative evaluations of companies’ development and EHR certification cultures, resulting in independent and comprehensive reports outlining areas of potential risk and noncompliance, as well as corrective action planning post-acquisition.
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Experience
- Regulatory and Certified Electronic Health Record Technology (CEHRT) services
- Office of the National Coordinator for Health Information Technology (ONC) 2015 Edition CEHRT audits
- Electronic health record (EHR) nonconformity disclosure and corrective action planning
- EHR Incentive Program and CEHRT education
- CEHRT program best practice documentation standardization
- CEHRT best practice operational restructuring and implementation
- Software Quality Oversight Organization (SQOO)/monitorship
- Executive coaching and interim executive staffing
Engagement Examples
- BRG professionals were retained by an EHR developer to perform a CEHRT audit to identify nonconformities and assess compliance with the ONC 2015 Edition CEHRT requirements and federal regulations. BRG experts performed a detailed audit of all certification criteria, focusing on the impact to patient safety, patient engagement, and clinician usability. BRG collaborated with the client to identify and document areas of noncompliance and develop strategies to address deficiencies.
- BRG professionals conducted multiweek, intensive, cross-divisional workshops for an EHR developer’s product management and development staff to mitigate the developer’s ONC CEHRT criteria failures and misinterpretation of applicable regulations. The workshops consisted of education and an evaluation of the EHR’s functionality. BRG experts collaboratively managed and prioritized the software development remediation process, including developing comprehensive design documents and client-facing documentation.
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Our industry knowledge is broad and deep.
BRG combines intellectual rigor with practical, real-world experience. We have an in-depth understanding of industries and markets, with expertise spanning the major sectors of the global economy. Following are some of the many sectors that we know inside and out.