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Lewis Carroll wrote in Alice’s Adventures in

Wonderland & through the Looking-Glass, “If

you don’t know where you are going, any road

can take you there.”

That has been an apt description of the alignment of healthcare pay-

ment and outcomes for some time. The roads are getting clearer

and the destinations and goals measured and paid for are becoming

more distinct. But new entrants and competition are disintermedi-

ating legacy providers and therapies, changing the determination of

value for companies, therapies and episodes of care. This is disrupt-

ing traditional methods of value validation in the process.

THE NEW MEASUREMENT OF VALUE IN MEDICINE: UNDERSTANDING OUTCOMES & COMPETITION IN A CHANGING INDUSTRY By David Friend and Patrick Pilch

THE NEW MEASUREMENT OF VALUE IN MEDICINE: UNDERSTANDING OUTCOMES & COMPETITION IN A CHANGING INDUSTRY ...................................................................1

THE EVOLVING CYBER THREAT & HOW HEALTHCARE CAN MITIGATE IT...............................................................6

DID YOU KNOW?.............................................................................8

BLOCKCHAIN COULD BE THE ANSWER TO HEALTHCARE’S INTEROPERABILITY PROBLEM............10

MEET OUR TEAM..........................................................................13

SUMMER, 2017

HEALTHCARE NEWSLETTER

HEALTHCARE INDUSTRY UPDATES

CONTENTS

Social Security Number Removal Initiative (SSNRI)

Critical Access Hospitals: Optional Payment Method

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WHAT IS VALUE AND HOW DO YOU MEASURE IT?

In financial terms, value is often measured by discount-ing projected future cash flows back to the present. This has been an acceptable approach in many industries, including healthcare. However, value changes over time, as the sense of the future evolves.

Case in point is the rise and demise of Tower Records. In the 1980s, when the music industry distribution mod-el increasingly utilized specialty focused full-service re-cord stores, Tower Records flourished. By 2006, Tower Records filed for bankruptcy, brought on by debt that supported an aggressive expansion strategy that failed to understand that music downloads (plus streaming services) were becoming a new competitive force to Tow-er as an alternative, personalized distribution channel. Tower Records’ failure to recognize new forces of com-petition and innovation was fatal. By adhering to a fa-cilities-driven channel strategy and continuing to pursue the wrong capital strategy, the company ended up with too much inventory and facility capacity, which ultimately led to its demise.

For the healthcare industry, as care becomes more consumer-focused and personalized, new entrants and competition are coming into the industry. In addition, reimbursement is migrating to episode-based bundles. The industry is facing a disruption scenario much the same as Tower Records. The value of healthcare assets is changing as their respective importance and efficiency shift risk and worth.

As Michael E. Porter, Harvard Business School profes-sor and author of Redefining Health Care: Creating Val-ue-Based Competition on Results, said: “The only way to truly reform healthcare is to reform the nature of com-petition itself.” This means disintermediation of incum-bent players by new participants, (think the iPhone or Pandora vs Tower Records) new models (think streaming music vs buying vinyl records), diagnosis and measure-ment (think machine learning and artificial intelligence vs “American Top 40”).

The failure of many leading healthcare organizations to grasp this change is leading to an over-weighted, facili-ties-driven channel strategy, an inefficient capital strat-egy continuance and ultimately, costly facility capacity. There is no reason to believe the story of healthcare will

end any differently than it did for music.For healthcare institutions to survive and thrive, they will need to understand the nature of competition, how to create and measure value, and how to create sustain-able competitive advantage through effective risk man-agement and clinical performance. While this counsel may appear to be redundant to existing practices, chang-ing payment and quality measures, new competition and innovative forces are converging into a power that can’t be ignored.

Healthcare institutions (including all providers of care and therapies like pharmaceuticals, life sciences, bio-tech and medical devices) will also need to understand how to respond to the demands of the federal and state governments, which will impose regulatory and policy di-

rectionality. They’ll also need to know how to concurrent-ly please consumers and payers who continue to look for the best value based on cost, quality and experience.Market (innovation and revolutionary forces) and regula-tory drivers must be synthesized to plan for a new model that can work profitably and sustainably. These factors are converging to change delivery, pricing, access and value.

MARKET DRIVERS

A profound movement of care has taken place from hos-pitals to non-hospital settings. This shift will only accel-erate as integrated supply chains emerge to address high-cost fragmented care and therapies, and mobile technologies and telepresence access points continue to flourish in a world embracing greater site neutrality (think of music downloads and smartphones as compa-rable distribution channels).

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The convergence of molecular biology and computer science is already having a notable impact on value by displacing existing protocols and delivery models. Witness the emergence of digital life sci-ences in its displacement of legacy ana-log procedures in the diagnostic space. Lastly, there has been negative return on capital for healthcare companies. This is remarkable, as healthcare invest-ment has historically been a stalwart with steady returns.

REGULATORY DRIVERS

Policies at the federal and state levels are changing, as well. The Obama administra-tion focused on policies to speed up the adoption of payment reform through man-dates, regulatory enforcements and sub-sidies. While the Trump administration’s policy counterpoints of choice—compe-tition and actuarial soundness (possibly with assistance from tax credits)—are different approaches from the previous administration, payment reform accelera-tion is still on track. Adding to the mix, ag-ing populations and increases in co-mor-bid and chronic illnesses are demanding resources from strained budgets.

At the state level, payment reform, par-ticularly in Medicaid, continues to be ex-plored as state budgets experience strain because of growing pension obligations and tax revenue shortfalls. At least 22 states face budget shortfalls for the cur-rent or next fiscal year or biennium (two-year schedule), according to the National Conference of State Legislatures’ Spring 2017 State Budget Update. Thirteen states will face a shortfall in both cycles. The report does not attribute shortfalls to any one cause, but lists a range of causes for many states, including “demographic changes, low energy prices and a sluggish agricultural economy.”

These market and regulatory driv-ers have led to varied responses, but clearly the healthcare ecosys-tem is experiencing shifts that ultimately affect the way, where, how and when patients receive care. Moreover, the focus of val-ue has shifted to improving the patient experience and the qual-ity of care while lowering costs. Payment reform in the context of federal and state Medicaid mod-els and bundled payments, and aligning episodes of care with payment will continue to change what “value” means.

It is clear there is a mispricing of healthcare assets, which sets the stage for significant arbitrage opportunities between presumed value and actual value. The high-est-cost provider of care and ther-apies are at the greatest risk of loss through disintermediation. The arbitrage gap accelerates with “industrialization” of health-care through the integration of supply chains. Risk capital and

the competence of the clinical enterprise will determine how efficiently providers of care and therapies will extend value multi-ples on assets. Exceptions to this likelihood—albeit temporary—in-clude defenses associated with patent protection, price/clinical outcomes superiority to market and, in some instances, geo-graphic dominance with full risk providers.

Existing regulatory barriers en-forced through anti-kickback pro-visions and a volume-based pre-disposition held onto by hospital providers may stall near-term ac-ceptance. Still, value-based phar-maceutical agreements will begin to take hold, and providers, phar-ma companies, patients and pay-ers will participate in value-based therapies and networks. The fed-eral policy favors this.

Source: Kaiser/HRET Survey of Employer-Sponsored Health Benefits, 2006-2016

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THE CHANGING MODEL OF HEALTHCARE

PAYMENT (COSTS)

Moving payment from fee for ser-vice (reimbursement for every ser-vice) to value based (payments tied to outcomes) has been underway for some time, and there is certain-ly much further to go. The cycle of a fragmented payment system leading to fragmented care and an unsus-tainable healthcare system leads us to payment reform. Rising costs and outcomes not appropriately aligned have laid a foundation for the transi-tion to value-based payment.

As seen in the data from Kaiser above, over the course of 10 years, employer contribution grew from $8,508.00 to $12,865.00, with a compound annual growth rate, or overall return, of 4.22 percent. The cumulative rate of inflation approxi-mates 19.1 percent, or 1.91 percent on a compounded annual growth rate.

Also seen in the data above, over the course of 10 years, worker con-tribution grew from $2,973.00 to $5,277.00, with a compound annu-al growth rate, or overall return, of 5.91 percent. The increased cost of health insurance for both employers and workers has changed the deri-vation of value into the consumers’ hands.

There is a profound risk shift occur-ring that is changing the way health-care and pharma/life sciences as-sets will be valued. The risk shift is from payer to consumer or interme-diary. For example, the federal gov-ernment continues to shift financial

risk to the states and the population. Large employers have become in-creasingly self-insured, and they too have shifted risk to employees. Pro-viders and provider systems have as-sumed greater risk associated with value-based payment, while insurers have decanted their risk by position-ing themselves as service providers to those entities (providers, self-in-sured employers and individuals) where someone else is backstop-ping the risk.

When considering value, measure-ment systems need to be put into place to collect and measure viable data on performance, ensuring they meet accepted standards. This val-ue-based payment model shows a clear movement toward consumers determining value in healthcare.

DELIVERY OF CARE (PATIENT EXPERIENCE)

There has been a shift away from in-

stitutionalized care to site neutrality where the site may be virtual or a step-down unit or location. The dein-stitutionalization of care calls for site neutrality and creates other types of

competition, often generating excess capacity in hospitals. To improve val-ue for traditional “bed-driven” mod-els, sites now need to realign beds with the right acuity and payer mix, leveraging its “circle of clinical com-petence.” Again, the application of a value-based pharmaceutical agree-ment will change the delivery of care model, particularly in new therapies.

In the shift from volume to value, the value multiple shifts from capacity to the circle of clinical competence and its ability to reproduce value (clinical outcomes) efficiently. Investment consideration and due diligence need to take this into account. It is not a simple exercise but certainly an important one.

TYPE OF CARE (QUALITY)

Value used to be tied to the number

of specialties provided, particularly for acute care providers. The result

has created important service lines in hospitals and often redundancy of services in a market.

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It has also generated a rush to develop competitive, but not necessarily differentiated, offerings to serve the market and drive volume to achieve revenue goals and absorb capacity availability. Bundling of care and payment is partic-ularly disruptive on existing fee-for-service models and the effect could be either punitive or beneficial. The deter-mining factor is the company’s circle of clinical competence—is it leverageable, and can it be extended efficiently? Though it has abated, the trend had been to organize care around Centers of Excellence for Advanced Medicine to build a strong reputation.

Now, models will move to be aligned more specifically around episodes of care as payment for care is rapidly moving to cover an episode of care which addresses acute and post-acute care delivery. Again, as capacity value diminish-es, the circle of high clinical competence value flourishes.

THE PATH TO SUCCESS

Ultimately, regulators and payers (institutional and individual) are assessing and validating prices, quality and pa-tient experience, which are determining value. Awareness and placement of the arbitrage risk is essential. The patient is the measurable determinant. Competition for differentiation by value requires assessment of cost of care to market and to the possible, understanding what clinical competence is needed to deliver value, and where a company can perform optimally in the supply chain of care as measured by how efficiently a company can repro-duce assets. Clearly, there will be winners and losers, and many significant. Our counsel is to seek understanding of value; know where your company’s assets are participating in the supply chain and how well its circle of clinical competence can reproduce value through clinical outcomes more efficiently than the market on a sustainable basis.

As we started, we finish with what Lewis Carroll wrote in Alice’s Adventures in Wonderland & Through the Look-ing-Glass: “Where should I go?” asked Alice. “That depends on where you want to end up,” replied the Cheshire Cat.

WannaCry sent a message: Healthcare has a target on its back, and cyber-attack-ers have homed in on the mark.

When the May 12 ransomware at-tack unleashed more than 75,000 ransomware attacks across the globe and harmed a notable por-tion of the U.K.’s healthcare sector, U.S. healthcare organizations were largely spared because of a virtual, but temporary, kill switch discov-ered before the malware made its way across the pond.

But it would be dangerous for the U.S. healthcare sector to consider itself immune or even less vulner-able, particularly as current cyber threats grow and new ones emerge, directly targeting the sector and its data.

In 2016, the U.S. healthcare sector saw a record number of large-scale data breaches (those affecting 500 or more patients). According to data from the Department of Health and Human Services’ Office for Civil Rights (OCR), 327 large-scale data breaches were reported last year,

compared to 199 in 2010. In 2017, the industry has already seen its fair share of large-scale data breaches, with 130 reported as of June 13.

OCR defines an information breach as “an impermissible use or disclo-sure under the Privacy Rule that compromises the security or privacy of the protected health information (PHI).” It breaks types of information breach into seven categories: hack-ing/IT incidents, improper disposal, theft, unauthorized access/disclo-sure, unknown and other.

*Data source: OCR’s Breach Portal**As of June 13 and measured by the number of individuals affected

THE EVOLVING CYBER THREAT & HOW HEALTHCARE CAN MITIGATE IT

By John Riggi and Patrick Pilch

Healthcare Newsletter www.fcc-cpa.com Spring, 2017

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Each type of information breach can be defined as:

• Hacking/IT incidents: Inci-dents involving insider or outsid-er intrusions

• Improper disposal: Incidents in which PHI is improperly dis-posed

• Loss: Incidents in which a de-vice containing PHI is lost by the organization or an employee

• Theft: Incidents in which a device containing PHI is stolen from the organization

• Unauthorized access/disclo-sure: Incidents in which inside or outside actors either access restricted areas of the organiza-tion’s network or disclose PHI to an unauthorized recipient

• Unknown: Incidents in which data is not reported or missing

• Other: All other types of inci-dents

SHIFTING THREATS

The type of security breach posing the largest threat to the industry has evolved over the last seven years from theft to unauthorized access or disclosure of data.In 2010, theft was the most common type of information breach, compris-ing 135 of the 199 reported inci-dents (68 percent). Hacking or IT in-cidents and unauthorized access or disclosure breaches remained lower, with each making up 8 percent of all reported breaches.

By 2016, 129 (29 percent) of breach-es involved unauthorized access or disclosure, while 113 (35 percent) were associated with hacking or IT incidents—making these two breach

types the greatest threats to the healthcare industry, which holds true today.

NUMBER OF LARGE-SCALE BREACHES BY YEAR*

*Note: Each count is the total number of reported breach incidents of the specific information source and breach type. Individual reports of a breach may involve or more breach types (theft, loss, etc.). In those cases, there may be double-counting of the number of reported incidents or reported breaches in a specific year.**As of June 13, 2017

*Note: Chart created using data from OCR’s Breach Portal

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Theft breaches followed (62 incidents), then data loss (16 incidents) and, finally, improper disposal (7 inci-dents).

MITIGATING EVOLVING RISKS

The human element presents the greatest cyber risk of all. The most important step to mitigating this risk is to implement proper access controls including file, direc-tory and network share permissions with least privilege in mind. But a broader, well-rounded and documented cybersecurity plan is crucial and should address the fol-lowing:

• Risk assessment. Entities should perform regular risk assessments through which they can identify and classify their assets, risks, threats and vulnera-bilities.

• Data/network mapping and access control/management. Entities should know where all HIPAA information is stored, how it traverses the network and the security around that data—who has access, who has control and who has what privileg-es?

• Device monitoring. Crucial when it comes to theft breaches, mobile device management (MDM) can alleviate some of these human error risks. Entities should know about every mobile device in their or-ganization that contains personal health information (PHI).

• Third-party due diligence. Vendor systems can be an access point or weak link in an organization’s protection. Third-party risk due diligence must be done through the prospect, initiation and ongoing relationship stages to isolate changes in risk and vulnerability postures.

• Top-down security mindset that supports staff-ing and training. Board members should be in-formed and proactive in taking ownership of cyber-security. Organizations should ensure they have a dedicated information security function that reinforc-es cyber awareness throughout the organization.

• Well-documented policies, standards and procedures. Providers should document their cy-bersecurity mindset and be able to produce specific guidance, like their cyber incident response plan, the types and frequency of network security tests performed, and training protocols.

A proposed CMS rule that would require Medi-care to consider hospitals’ proportion of du-al-eligible patients when calculating penalties under the Hospital Readmissions Reduction Program garnered more than 4,000 public comments. Medicaid enrollees are, for the most part, happy with the healthcare they receive under the program, a study published in July by the Harvard T.H. Chan School of Public Health revealed. Under the Affordable Care Act, Med-icaid was expanded in 31 states and D.C.—un-derlining the challenges Congress faces as it takes on healthcare reform.

The number of uninsured adults in the U.S. has increased by about 2 million in 2017, with the uninsured rate increasing to 11.7 percent in Q2 compared to a record low of 10.9 percent at the end of 2016, according to the recently published Gallup-Sharecare Well-Being Index.

The rate of serious medication mix-ups has doubled since 2000, according to a new study from the U.S. National Poison Data System, with four out of 10 mistakes involving heart medications, painkillers or hormone therapy prescriptions like insulin. Many times, the er-rors result in hospitalizations.

DID YOU KNOW?

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Additional cybersecurity resources can be found here:

• Introducing SOC for Cybersecurity: Translating Cyber Risk for Every Stakeholder

• U.S. Government Introduces Healthcare Cybersecurity Resource Website

• Network Segmentation Key to Mitigating Ransomware Risk for Hospitals

• FBI Warns Healthcare Facilities About Cyber-vulnerable FTP Servers

• How Hospitals Can Improve Cyber-response by Forging a Stronger Relationship Between Counsel & IT

• WannaCry: How Healthcare Organizations Can Protect Against it & Other Ransomware Strains

Additionally, the FBI recommends the following miti-gation measures specific to ransomware attacks like WannaCry:

• Apply the Microsoft patch for the MS17-010 SMB vulnerability dated March 14, 2017. (Organizations using unsupported Windows operating systems including Windows XP, Windows 8 and Windows Server 2003 should follow customer guidance from Microsoft.)

• Enable strong spam filters to prevent phishing e-mails from reaching end users and authenticate in-bound e-mail using technologies like Sender Policy Framework, Domain Message Authentication Reporting and Conformance, and DomainKeys Iden-tified Mail.

• Scan all incoming and outgoing e-mails to detect threats and filter executable files from reaching the end users.

• Ensure anti-virus and anti-malware solutions are set to automatically conduct regular scans.

• Manage the use of privileged accounts, assigning administrative access only when absolutely needed.

• Disable macro scripts from Microsoft Office files transmitted via e-mail. Consider using Office Viewer

software to open Microsoft Office files transmitted via e-mail instead of full Office suite applications. Develop, institute and practice employee education programs for identifying scams, malicious links and attempted social engineering.

• Have regular penetration tests run against the net-work, no less than once a year, and ideally, as often as possible/practical.

• Test your backups to ensure they work correctly upon use.

The FBI also recently identified DeltaCharlie, a Distribut-ed Denial of Service (DDoS) Botnet infrastructure that North Korean cyber actors known as HIDDEN COBRA are using to target media, aerospace, financial and critical infrastructure sectors in the U.S. and around the world. Organizations should read the Department of Homeland Security (DHS)’s full alert on that here.

Organizations could also benefit from the HITRUST CSF, the most widely adopted security framework in the U.S. healthcare market which helps facilitate HIPAA compli-ance and cyber readiness. Read more information on that here.

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Healthcare has an interoperability prob-lem and it’s costing providers and payers money while leaving them open to compli-ance vulnerabilities.

As providers are increasingly required to coordinate with partners on the care continuum or risk reimbursement penalties, they are being asked to exchange their siloed data and keep track of reimbursement information and contractual processes with more third parties. The po-tential for inefficiencies, inaccuracies—and data securi-ty slipups—has never been higher.

Enter blockchain.

A permanent and distributed ledger of transactions that supports many different uses, from transacting in cryptocurrencies like bitcoin, to verifying information and contractual processes between a health plan and a patient, the technology could streamline the process of sharing information.

“Take a standard health plan/provider agreement, or in risk-based relationships, provider/provider agreements, where each provides the other with a paper contract. Each entity loads the agreement into their separate systems, and it defines their relationship,” wrote Bruce Broussard, CEO of Humana, on LinkedIn Pulse. “The payor also has a contract with each person who has pur-chased a health plan. Using blockchain, the health plan and provider could translate the wide variety of agree-ments needed to contracts on the blockchain so every-one has visibility, and clarity exists for both the provider and the member. So when a transaction is processed, the blockchain checks the authorization, and everyone can view the status, history and next steps.

“This transactional payment information could also be connected with the clinical service details to provide a holistic view of the patient’s interaction. Storing the information to create this holistic view in blockchain would create a foundation that enables interoperability and innovation across the industry.”

By using blockchain, providers and payers would do more than make the reimbursement process more streamlined and secure. They would also mitigate the growing risk for false claims because every alteration of information in blockchain is automatically recorded, creating heightened levels of transparency and account-ability. Moreover, as more clinical outcome information is gathered and iterated over time, effective prospective risk stratification and management can be deployed which, in turn, can improve planning.

Is there an example of applying blockchain in health-care, practically speaking? We use the audit process as an example of how the technology could be applied across the industry more broadly.

EXAMPLES OF BLOCKCHAIN IN THE AUDIT PROCESSBlockchain could provide a clear enhancement to sever-al aspects of audit and compliance processes, both of which can be resource-intensive.

These processes can trigger rounds of manual reconcili-ations, involve data that requires significant sampling or full testing, and demand hours of often-duplicative data analysis due to a lack of systems integration.

Efforts required to validate transactions manually can drive up the cost, stretch out the process and decrease the efficiency of the audit procedure. Distributed, elec-tronic ledgers make up the underlying structure of blockchain to maintain, in real-time, transactions that are validated and protected via encryption solutions.

What does that really mean?

BLOCKCHAIN COULD BE THE ANSWER TO HEALTHCARE’S INTEROPERABILITY PROBLEM

By Patrick Pilch, Sanjay Marwaha, Chuck Pine and Greg Schu

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A blockchain transaction could be validated when it occurs and can be reviewed for completeness and accuracy using entities that exchange transactions through a common platform. The auditor should be able to more quickly and efficiently reconcile data, amounts, assets, ownership, transactions and other detailed information across the distributed general ledger. Using the financial services industry as an example, the following is a current state over-view of an audit and compliance review process. In the context of healthcare, a provider, payer or fiscal intermediary would replace the bank in the process.

In the context of healthcare, the financial exchange is made through a payer or fiscal intermediary with the delivery of care or supplies or services vendor. Essentially by leveraging blockchain for audit and compliance activities, data transparency could be improved, and the need for duplicative and manual reconciliation and validation processes between healthcare organizations and across disparate systems would be greatly reduced.

Completeness and veracity of the data are essential, and there are concerns in any industry—specifically health-care, as payment methodology is undergoing significant redesign around clinical outcomes. The U.S. Department of Health & Human Services (HHS)’s Office of Inspector General (OIG) designated the improvement of Medicaid data as a top management challenge, creating the Transformed Medicaid Statistical Information System (T-MIS) to address it by better understanding the care delivered to Medicaid patients—a population of 70 million. In a June 26 report about the implementation status of T-MIS, though, the OIG raised a prominent level of concern regarding the “completeness and reliability” of the data coming from T-MSIS.

Source: World Economic Forum

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“Specifically, states indicate that they are unable to report data for all the T-MIS data elements,” the report noted. “Additionally, even with a revised data dictionary that provides definitions for each data element, states and CMS report concerns about states’ varying interpretations of data elements. If states do not have uniform interpretations of data elements, the data they submit for these elements will not be consistent across states, making any analysis of national trends or patterns inherently unreliable.”

Blockchain could be a solution to this challenge.

By making transactions available in real-time, blockchain technology can help reduce the potential for errors and improve the overall quality of the healthcare audit process. If the initial transaction is audited, blockchain allows for a self-auditing process and, thus, allows a greater level of assurance. With the added automation and integration of systems, blockchain has the potential to shorten the time required to perform the testing and validation of the infor-mation. Again using financial services as an example, below is a potential future state of an audit and compliance review process leveraging automated solutions such as blockchain, whereby a provider, payer or fiscal intermediary would replace the bank in the process.

Using blockchain in healthcare is still a novel idea, but the possibilities it presents to the industry are endless. Bun-dled payments, clinically integrated networks and risk management are additional areas for development and use.

Source: World Economic Forum

These articles originally appeared in BDO USA, LLP’s “Healthcare Industry Insights” newsletter (Summer, 2017). Copyright © 2016 BDO USA, LLP. All rights reserved. www.bdo.com

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