AJMC
`
`(iil
`
`Observations Regarding the Average Sales
`Price Reimbursement Methodology
`
`June 21, 2021
`Susan Weidner,MBA,MS, Michael Diaz,MD, Cass Schaedig,
`Lucio Gordan,MD
`Evidence-Based Oncology, June 2021, Volume 27, Issue 4
`
`Pages:SP156-SP160
`
`Introduction
`
`g FLORIDACANCER
`
`SPECIALISTS
`& Research Institute
`
`World-Class Medicine. Hometown Care.
`
`___
`
`In the United States, CMSis the single largest payer for health care. In 2019, Medicare
`enrolled more than 60 million beneficiaries, and enrollment is expected to exceed 80 million
`by 2030.12 Medicare Part B provides coveragefor beneficiaries for drugs and biologics that
`are administered in physician offices or hospital-basedclinics by infusion orinjection.It also
`covers certain other drugs, including someoral anticancer therapies, oral antiemetics,
`immunosuppressive drugs, and homeinfusions.° In 2017, 7 of the top 10 drugs reimbursed
`by Medicare Part B were mainly, or exclusively, for oncology or related supportive care
`indications and accountedfor over $8.7 billion in spending.* This amount is expected to
`increase as the majority of new cancersin the United States are diagnosed in the Medicare-
`aged population, which is expanding as baby boomersage.®
`
`— Medicare Part B Reimbursement Methodology
`Medicare Part B provides reimbursementat a rate of the average sales price (ASP) plus a
`6% add-on fee (ASP 6), a methodologythat relies on market-based prices to set
`reimbursementrates.®© The 6% is provided as an add-on paymentto cover expensesrelated
`to the needs of physician-administered drugs. Amongtheseare purchasingvariability,
`shipping fees, complex administration, ongoing patient monitoring and education, and
`overheadfor storage and handling requirements.”®
`
`ASP wasenactedin 2005 as part of the Medicare Prescription Drug, Improvement, and
`— Modernization Act of 2003 and generally reflects the average price of a drug'ssalestoall
`purchasersin the United States, including commercial payers. The ASPis calculated for
`each Healthcare CommonProcedure Coding System (HCPCS)codeincluded in Part B
`coverage with a 2-quarter lag, as shownin Figure 1. HCPCS codes mayinclude drugs from a
`single source or, more commonly, from more than 1 manufacturer. Drug manufacturers
`provide data forthe calculation to CMS quarterly.®
`
`—
`
`Figure 1.
`
`As HCPCScodesfrequently include drugs from multiple manufacturers, ASP 6 provides
`reimbursement at 106% of the blended ASPforall products within an HCPCS code on a
`
`Exhibit 2268
`Page 01 of 23
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`methodology currently in use for Medicare Part B. Additionally, due to a knownerror
`surrounding prompt-pay discounts provided to distributors but not passed onto providers,
`actual realized reimbursementis likely closer to ASP plus 2.3%.
`
`(iil
`
`Issues Facing Medicare Part B Reimbursement
`Despite a paucity of published data, the Medicare Payment Advisory Commission (MedPAC)
`provided a report to Congressin 2017 detailing their concerns with ASP. which included a
`lack of competition creation and the potential for incentivizing providers to choose higher-
`priced drugs.'° Additionally, Ridley et al recently published a conceptual model showing that
`launch prices have increased underthis reimbursement model dueto its reliance on lagged
`pricing.'' These publications maintain the perception that physiciansare incentivized and
`driven by increased prices of drugs and that higher prices indicate higher profit and margin.
`In this review, we will explore recentliterature that provides evidence directly contradicting
`these concerns.
`
`In 2018, President Trump's administration proposed American Patients First: The Trump
`Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (Trump
`Blueprint). This proposed policy included aggressive concepts such as new negotiation
`tactics for Part B drug prices, movement of somedrugs covered underPart B to Part D to
`allow for formulary managementandutilization review, reimbursementfor therapies based
`ontheir indication, an international pricing index (IPI), flat administration reimbursement,
`and higherprices for therapies when usedoff -label, among others.'*'? The impact ofthis
`policy on the ability of community
`oncology practices, where the majority of patients receive their anticancer care, to continue
`to provide optimal care to patients—with potential reductions in reimbursement—is
`concerning.
`
`As part of the Trump Blueprint, reimbursement could have changedtoa flat fee add-on
`paymentrather than a percentage-based add-on payment."4 The addition of the percentage-
`based add-on paymentin the Medicare Modernization Act, was intended to ensure that
`providers are reimbursed for overhead costs, such as proper storage of medications,
`compounding compliance, and sdministration of complex regimens, amongothers.!°
`However,flat fee add-on paymentsare highly unlikely to captureall the nuances and
`complexities of cancercare. A flat fee is not dynamic, meaning it cannot reflect market and
`inflationary pressures and does not account for multidrug, complex treatment regimensor
`the administration of necessary supportive care medications.'> This proposed changein
`add-on fee structure could result in inconsistencies in reimbursementfor any site of service
`and eventually prevent the delivery of proper care as far as treatmentselection. It also
`would restrict accessto care, as it would likely disproportionately affect vulnerable smaller
`practicesin rural locations or underserved areas.
`
`In a volatile political environment with potential policy changes that could affect more than
`60 million Americans,it is important to understand the basis of the current Part B
`reimbursement system andthe current benefits of ASP that would be imperative to preserve
`for future success. Herein, we aim to review ASPin the context of oncology therapies and
`provide comments on its methodology, as well as present our research onalternative
`models that may be employedin the future to ensure sustainable oncology practices.
`
`Exhibit 2268
`Page 02 of 23
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`methodologyindicates that the driving force in product selectionis clinical effectiveness.
`Data suggest that ASP has lowered drug prices, reduced variation around drugpricing,
`limited year-over-yearprice increases, reduced chemotherapy treatment within 14 days of
`death, and discouraged the useof higher-priced drugs.'”28
`
`(iil
`
`Additionally, ASP has loweredoverall Part B drug spending. As noted above, before ASP
`Part B drug spending wasrising at an average of 25% per year. Under ASP that rate dropped
`to just 4.4% per year and, after adjusting for inflation, drug spending rose from 2007 to 2013
`at an annualrate of 2.8% for all Part B drugs.° Despite the entrance of numerous expensive
`biologics and targeted therapies, the total payments, numberof units, and weighted ASP
`remainedflat from 2006 to 2014.”7°
`
`In recent years, drug spending has beenincreasing rapidly. Between 2005 and 2016,total
`drug spending grew at an averagerate of 7.4%, with slower growth from 2005 to 2009 (3.7%
`per year) and more rapid growth from 2009 to 2016 (9.5% per year). This drugs, including
`the adoptionof new,higher-priced drugs.* However,the price growth from 2006 to 2015
`(Figure 2) for Part B wasstill lower than that of Part D, in part due to ASP reimbursement
`methodology.
`
`Figure 2.
`
`THE ASP PAYMENT
`
`METHODOLOGY AVOIDS
`
`PRICE SETTING BY
`
`GOVERNMENT
`
`AGENCIES AND ITS EXTENSIONS WHILE YIELDING MARKET-DRIVEN REIMBURSEMENT
`
`RATES NEARORAT ACQUISITION COST. In contrast to Part D, Part B reimbursementlacks
`gross-to-net issues, as value is eventually returned back to Medicare and patients. Gross-to-
`net issues exist when rebates and discounts are provided for high-cost drugs and then
`absorbed by pharmacy benefit managers (PBMs)or other intermediaries to off set part of
`the cost of nondrug treatments to reducetheir patient premiums. This contract mechanism
`results in a large disconnect between the gross revenues and net revenuesrealized by drug
`manufacturers,increasing pressure on an already fragile system.”° Using ASP methodology
`allows Part B to avoid this issue and provides further evidence that moving Part B drugs to
`Part D, as proposed by the Trump Blueprint, would have presented new andlarger problems.
`
`THE ASP METHODOLOGY ELEGANTLY CREATESFINANCIAL RISK FOR THE PROVIDER
`
`THATIS DIRECTLY PROPORTIONALTO THE COST OF THE DRUG CHOICE AND NOT
`
`REPLICATED SO PRECISELY BY NUMEROUS ALTERNATIVE PAYMENT MODELS UNDER
`
`DISCUSSION.Physician incentive programs currently being explored, including shared
`savings, pay-for-performance, medical home, and those of accountable care organizations,
`presentlogistical issues: they are potentially difficult to understand and diffuse, and too far
`removedin timeto beresilient reinforcements of individual physician behavior. In contrast,
`the ASP methodology and the risk associated with buy-and-bill or fee-for-service systems
`for providers are precise, tangible, immediate, and directly proportionate to the cost
`resulting fromaclinical decision.2? Considering the lag time of ASP there are several
`nuancesfora providerto considerin terms offinancing their practice.°° When a provider
`purchasesa drug for a specific patient, they immediately incurthe financialrisk as a direct
`result of that decision. Under a standard transaction, they are reimbursed by Medicare
`
`Exhibit 2268
`Page 03 of 23
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`

`than 1% for only 5 of 18 drugs (range, 1.4%-7.8%). Theillustrates the fact that despite a
`lowereffective market price in some instances, ASP reimbursement methodology can
`maintain an appropriate reimbursementrate that is reflective of the market in the majority of
`cases.°"
`
`Minimal evidence exists to indicate that drugs are overutilized, with most never reaching
`their “brand-potential index”-—in other words, the total numberof patients who canreceive
`the drug basedonits indication(s). Furthermore, multiple publications have indicated that
`oncologypractitioners are unlikely to changetheir treatment patterns ortheir decision to
`administer treatment to cancer patients, even when offered a higher reimbursementfor
`using specific drugs.2492
`
`THE CURRENT ASP METHODOLOGY PROPERLY ALIGNS PHARMACEUTICALPRICING
`
`BEHAVIORIN THE DIRECTION OF PRICE INHIBITION BY INCLUDING MANDATORY
`
`REPORTING DOMAINSIN THE ASP CALCULATION.Although discounts and rebates given
`to intermediaries, such as PBMs,are not considered in the ASP calculation (because those
`price reductions are passed through subsequententities), rebates and discounts given to
`purchasing providers through ASPare included. This results in lower reimbursement rates
`and savingsto the Medicare program. As noted above,otheractivities that are deemed to
`reduce the purchaser's costare also included in the ASP calculation.® This inclusion
`restricts the pharmaceutical industry from directly influencing drug selection through pricing
`mechanismsand provides a benefit to Medicare—and,ultimately, patients—via a lower
`reimbursementrate.
`
`Impact on Generic and Biosimilar Use
`
`THE PRESENT ASP METHODOLOGYINHIBITS SIGNIFICANT YEAR-OVER-YEAR BRAND
`
`AND GENERIC DRUG PRICE INCREASES.To understandthis concept,it is important to note
`the 2-quarter lag between whensales occur and whenthe payment amountreflects those
`sales in the ASP methodology. This lag implies that price increases are absorbed directly by
`the provider for 6 months until the Medicare reimbursementrate for ASP is updated.
`Therefore, providers are required to purchasedrugs with the possibility of inadequate drug
`reimbursement.°2
`
`This scenario is illustrated in Figure 3, which showsthe impact of the 2-quarter lag on ASP
`reimbursementin a simplified version with an example drug. The WAC ofthe drug in Q1
`2017 has beenstable at $5500 and ASP-based reimbursementhasalso beenstable at
`$5300.In Q3 of 2017, the example drug's price increases to $7000 (as shownin the large
`red circle). Due to the 2-quarter lag in ASP-based reimbursement changes, the ASP 6
`reimbursement doesnot “catch up” to the WAC until 2 quarters later in Q1 2018 (as shown
`in the smaller red circle). The risk of this scenario creates a naturalinhibition to price
`increases for drugs dependent on PartBthatis not easily overridden by manufacturers
`without rendering products commercially inviable.°°
`
`Figure 3.
`
`ASP METHODOLOGY
`
`ENGENDERS LOWER
`
`GENERIC DRUG PRICING
`
`Exhibit 2268
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`(iil
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`predecessors. Providers are incentivized to prescribe the generic over the brand duetoits
`lower cost and reimbursement advantage, as depictedin Figure 4.
`
`This ability of the ASP methodologyto naturally spur lower generic drug prices is a hallmark
`of its successandis in stark contrast to that of the previous AWP system. However, the ASP
`methodology does more than lowerthe price.
`
`Figure 4.
`
`ASP INCENTIVIZES THE CONVERSION TO, AND CONTINUED USE OF, GENERIC DRUGS
`OVER THEIR BRAND INNOVATORS.In addition to the improved reimbursementthatis
`proportionate to the price decrease during the 2-quarter lag, providers also have the benefit
`of a markedly lowerrisk of bad debt when using generics as opposedto the higher-priced
`brand alternative. Therefore, even if price increases are seen in generics,the risk of
`inadequate reimbursement (Figure 3) represents a more reasonable monetary value than
`that of previous brand innovators. From the outset of a generic’s introduction and resulting
`price decreaseto its final lower price, the ASP methodology aligns Part B drug incentives for
`providers to use the lower-priced option and creates barriers for manufacturersto raise
`prices.°°
`
`CURRENT ASP METHODOLOGY ALLOWSFORDIFFERENTIAL REIMBURSEMENT
`
`ADVANTAGESFORBIOSIMILARS WHILE GENERATING LOWERPRICING. Just as ASP has
`
`created this situation for generics,it has likewise affected the biosimilar market. Similarto
`the addition of generics to the marketplace, the introduction of biosimilars is expected to
`lowerprices.
`
`Accordingto the Patient Protection and Affordable Care Act, reimbursementfor biosimilars
`will also be ASP plus 6%, but the 6% add-on is based onthe innovator product's ASP.°? This
`approachgivesthe biosimilar the advantage of a lowerprice with a proportionally larger
`add-on payment. Becauseofthe benefits, described throughoutthis paper, inherent portions
`of the ASP methodologyare worth preserving orimitating in future reimbursement
`methodologies.
`
`Alternative Reimbursement Methodology
`With the recent focus on drug price controls, such as the International Pricing Index Model,
`andcriticism of the current ASP reimbursement method, we investigated alternative ASP-
`based reimbursement methodsto determine whetherthey are worth pursuing. The
`objectives we desired with these alternatives included:
`
`Incentivizing the use of generics and biosimilars when available
`Continuing to support the sustainability of specialty practices ofall
`sizes
`
`e Supporting stability over time given changes in ASPs and drug mix,
`with Year 1 meeting at least ASP 6 in 2018
`Allowing providers to select appropriate therapies to meetindividual
`patient needs
`
`Exhibit 2268
`Page 05 of 23
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`

`(iil
`
`the average ASPper administration claim and then considered standard deviations from
`that average. Depending on how manystandard deviations from average, the claim was
`determinedthe thresholds applied and the reimbursement add-on.Details for these models
`are furtherillustrated in Table 2. Other tiered or capped models were evaluated but are not
`presented dueto theirfailure to provide the
`desired outcomes.
`
`Table 2.
`
`Results
`
`The reimbursement based on the proposed methodologies for 2019 is shownin Figure 5.
`Both the SD 3 andfixed tier methodsare ator slightly above ASP 6. Each modelaff ected
`drug categories differently relative to ASP 6. The SD 3 modelhadthelargest effect on the
`targeted therapy category, which represents some of the greatest costs of oncology care;
`the effect of the fixed tier model on these categories distributed the add-on to incentivize
`the use of lower-cost drugs, such as chemotherapy and supportive care. The effects offixed
`tier and SD 3 models relative to ASP 6 are shownin Figure 6.
`
`Figure 5.
`
`Figure 6.
`
`Practice settings were divided into 3 sizes: those with 5 or fewer medical doctors (MDs),
`those with 6 to 10 MDs,and those with 10 or more MDs. The models affected each practice
`size differently. The fixed tier and SD 3 models generated results similar to ASP 6. The
`average reimbursement per administration is shownin Table 3.
`
`Finally, the impact of each modelon the top 30 drugs based ontotal ASP and claim volume
`were evaluated. The results are shownin Table 4.
`
`Table 3.
`
`Table 4.
`
`Future Directions
`
`Our research showedthat2 alternative methods, 1 based on tiered reimbursement and 1 on
`average reimbursementand standard deviation, were able to provide the benefits of ASP6,
`provide appropriate reimbursementto various sizes of oncology practices, and curb the
`growthrate of claims over time. These methodologies provide information for future
`methodsthat use ASPastheir basis and build upon this construct to provide reasonable
`
`Exhibit 2268
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`(iil
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`treatment, clinical experimentation, and clinical research with the multifaceted costs or
`savings of any given deviation from common standardsby spreading the direct and indirect
`cost or benefit of a given variance acrossa rangeof participants. Despite the difficulty of
`experimental design in public policy-based research,it is imperative moving forward that
`decisions regarding changes to Medicare Part B reimbursement be based upon empiric
`data. Currently, actuarial evidence rather than population-baseddatais utilized to estimate
`changesin price trends and adjustments to reimbursement. Additionally, recent criticisms
`of ASPare generally based on theoretical models; they lack the incorporation of
`confounding factors such as the uptake of 340B drug pricing, continued changesin pricing,
`and orphandrugslaunchingat high prices but then expandingto additional indications.
`
`Overall, ASP is a market-based tool that can be leveragedin the future to create a
`sustainable reimbursement modelthat is beneficial to patients, payers, and providers.
`
`For Appendix, see:
`www.ajmc.com/view/weidner-et-al-appendices
`
`AuthorInformation
`
`Susan Weidner and Cass Schaedig are with IntrinsiQ Specialty Solutions,
`AmerisourceBergenin Carrollton, Texas. Michael Diaz, MD, and Lucio N. Gordan, MD, are on
`the board of Florida Cancer Specialists and Research Institute in Fort Myers, Florida.
`
`CORRESPONDING AUTHOR:Susan Weidner, 5025 Plano Parkway, Carrollton, TX 75010.
`Susan.Weidner@Intrinsig.com.
`FUNDING:This work wasfundedbyIntrinsiQ Specialty Solutions.
`ACKNOWLEDGEMENTS:Wewouldlike to acknowledge Xcenda, LLC, for assistance with
`medicalwriting.
`
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`
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`13. Barlas S. Views conflict on Trump's drug-pricing blueprint: most actions facepolitical,
`legal, and technical roadblocks. PT. 2018;43(10):606-628.
`14. LaPointe J. Potential Medicare reimbursement demoto lower Part B drug prices.
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`part-b-drug-prices
`15. Sullivan M, Brow M,Isaiah E.Is tiered provider reimbursementon the horizon for
`Medicare Part B? Avalere. June 13, 2019. Accessed February 11, 2020.
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`part-b.
`16. PaymentPolicy for Prescription Drugs under Medicare Part B and Part D, 2019, Hearing
`Before the Subcommittee on Health; Committee on Energy and Commerce (2019)
`(statement of James E. Mathews,executive director, Medicare Payment Advisory
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`2020. http://www.medpac.gov/docs/default-source/congressional-
`testimony/04_30_2019_medpac_drug_testimony_for_eandc.pdf?sfvrsn=0
`17. Hornbrook MC,Malin J, Weeks JC, Makgoeng SB, Keating NL, Potosky AL. Did changes
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`prescribing? J Clin Oncol. 2014;32(36):4042-4049. doi:10.1200/JCO.2013.52.6780
`18. Conti RM, Bernstein AC,Villaflor VM, Schilsky RL, Rosenthal MB, Bach PB.Prevalence of
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`based cohort of medical oncologists.J Clin Oncol. 2013;31(9):1134-1139.
`doi:10.1200/JCO0.2012.42.7252
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`20. O’Neil B, Graves AJ, Barocas DA, Chang SS, Penson DF, Resnick MJ. Doing more for
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`27. Colla CH, Morden NE, Skinner JS, Hoverman JR,Meara E. Impact of payment reform on
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`0i:10.1200/JOP.2012.000539
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`28. Weight CJ, Klein EA, Jones JS. Androgen deprivation falls as orchiectomyrates rise after
`changesin reimbursementin the U.S. Medicare population. Cancer. 2008;112(10):2195-
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`29. Fein AJ. The gross-to-net bubble reached a record $166billion in 2018 Drug Channels.
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`to-net-bubble-reached-record. html
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`30. Medicare payments for newly available generic drugs. Department of Health and Human
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`31. Medicare Part B: data on coupon discounts needed to evaluate methodology
`for setting drug payment rates. Government Accountability Office. July 27, 2016. Accessed
`January 15, 2020. https://www.gao.gov/products/AO-16-643
`32. Yasaitis L, Gupta A, NewcombC, Kim E, NewcomerL, Bekelman J. An insurer's program
`to incentivize generic oncology drugsdid not alter treatment patterns or spending on care.
`Health Aff (Millwood).
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`33. Patient Protection and Affordable Care Act, 42 USC §18001 (2010).
`34. Holahan J, Blumberg L. Capping provider payment. The Century Foundation. January 5,
`2018. Accessed January 15, 2020. https://tcf.org/content/report/capping-provider-
`payment/
`35. LaPointe J. Understanding the value-based reimbursement model
`landscape. RevcycleIntelligence. September 9, 2016. Accessed January 15, 2020.
`https://revcycleintelligence.com/features/understanding-the-value-based-reimbursement-
`model-landscape
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`
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`
`
`
`[Downioadkis]J)DownloadIssue:June2021
`
`With No Replacement for OCM on Horizon,
`Oncology Practices Ask: What Now?
`
`November22, 2021
`Gianna Melillo
`
`Evidence-Based Oncology, December 2021,
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`value-based care at OneOncology.“I’m afraid that priority on a next-generation cancer model
`maybe even moredelayed than someof us had hoped.”
`
`Aspart ofits strategic refresh announcement, Elizabeth Fowler, PhD, JD, deputy
`administrator of CMS and director of CMMI, said the center did not plan to end any models
`early, although objectives of the refresh will guide revisions to existing models and
`consideration of future models.
`
`The new approachwill also focus on a “streamlined portfolio of models,” as the previous
`volumeled to confusion amongparticipating practices. “In addition to reducing overlap, we
`also want our models to be simpler and easierto participate in, with less administrative
`burden,” Fowlersaid.
`
`CMSdeclined to commentdirectly for this article. A spokespersonsaid thereis likely to be
`some gap betweenthe end of OCM andthestart of any potential oncology model.
`
`Uncertainty Grows
`
`This raises a myriad of challenges and questions for those enrolled in OCM who have
`complied with data reporting and operational requirementsfor the past 5 years. Whenit
`launched, OCM wasto expire in 2021, but due to the pandemic, a proposed successor
`model called Oncology Care First was shelved.
`
`“It actually feels more like a void than merely a potential gap in the comprehensivecarethat
`a lot of patients are now receiving and benefiting from under this model,” said Karen L. van
`Caulil, PhD, president and CEO ofthe Florida Alliance for Healthcare Value.
`
`Intended to increase value-based care in the oncologyfield, OCM provides participants with
`monthly enhanced oncology services (MEOS) paymentsin addition to regular fee-for-service
`Medicare payments. Whetherpractices will receive bridge payments to continue funding
`services such as navigators and 24/7 record access until a new model is implemented
`remainsto be seen.
`
`“What do you do whenyoudon't have those payments anymore?” asked Schleicher. “We're
`lucky Tennessee Oncologyis very large, and we will continue to provide high-quality care
`that we've learned to do through OCM.Butif you're a small practice, | worry, are practices
`going to haveto revert back to the old ways of doing things where they don't have support
`from Medicare along the way?”
`
`Amidthis uncertainty, the Community Oncology Alliance (COA) called on CMMI to extend
`OCMthrough December31, 2022.° In a letter sent November16,the groupcited the
`investmentthat practices have madein the model, along with the effect the model has had
`on patient care. COA also argued that some negative reviews of OCM, notably the Abt
`Associates’ evaluation,failed to capture later data that show practices becamebetter at
`implementing the modelovertime.*
`
`“The millions of dollars of taxpayers’ money invested in the OCM andthe dramatic
`successes of many independent community oncology practices participating in the OCM in
`enhancing patient cancer care while lowering treatment costs should be clear reasons why
`
`Exhibit 2268
`Page 10 of 23
`
`

`

`Challenges in OCM
`
`Despite mixed reports of success with the model, various shortcomings hinderedefficient
`implementation and participation for some practices and ought to be addressedin future
`iterations, experts argued.
`
`Because of OCM's structure, participation in the modelcould disincentivize providing care
`for underserved communities or high-risk patients. Despite meeting reporting requirements
`and following guidelines, practices serving populations with baseline poor health would
`necessarily have increased risks of worse overall outcomes comparedwith practices
`serving healthier populations. A paper presented at the 2021 meeting of the American
`Society of Clinical Oncology found, for example, that high-risk patients were, on average,
`$21,500 over target when undergoing autologous stem cell transplant, even with risk
`adjustmentfor this procedure.
`
`“Provider exposureto risk in the OCMis highly sensitive to factors at the cancer and patient
`level,” wrote the authors, whocalled for models that “modelrisk in moreclinically granular
`ways.”©
`
`In their strategic refresh, CMMI acknowledgedthis problem, which wasalso apparentin
`earlier additional models.
`
`“Myvision for the future of the agency, our programs, and the people weserveis
`straightforward: that CMS servethe public as a trusted partner and steward, dedicated to
`advancing health equity, expanding coverage, and improving health outcomes,” said CMS
`Administrator Chiquita Brooks-LaSure during the refresh announcement.
`
`Amonglessonslearned listed in an accompanying CMMI whitepaper, the center stressed
`that moving forward, health equity will be embedded into every model. This step was seen
`by manyas encouraging.
`
`“So far, models have focusedoncost, quality, and patient experience. [Adding] equity as one
`of the factors is a welcome change,” said Kashyap Patel, MD, CEO of the Carolina Blood and
`Cancer Care Associates, associate editor of Evidence-Based Oncology™, and president of
`COA.
`
`But rising treatment costs in the oncology space also posed a challengeto practices. OCM
`includes a reimbursement system based on a snapshotof time to calculate reimbursement
`rates for oncology treatments. Over the years as new, more expensive treatments were
`developed and approved, they were, at times, not accurately captured by the model. The
`model wassoill-equipped to handle major innovations that CMM initially did not even
`include chimeric antigen receptor T-cell therapy in the cost-of-care calculations.®
`
`Canceris a multifaceted disease with numerousvariations, types, and mutations. This
`heterogeneity complicates standardization of care—a key componentof other, more
`streamlined payment models.
`
`CMMI plansto begin the Radiation Oncology (RO) Modelin January 2022,’ a start date the
`American Society for Radiation Oncology has deemed “extremely challenging,” due in part to
`
`Exhibit 2268
`Page 11 of 23
`
`

`

`Ontheflipside, voluntary models allow practices to simply drop outatthefirst hint of a
`bleak financial forecast,limiting the quality and quantity of data produced by model
`participation.
`
`(iil
`
`During OCM’s 5-year implementation, changing conditions required by CMS and a lag in
`outcomereports meantpractices were unable to implement successfulpractices in a timely
`fashion.
`
`Looking Ahead
`
`Moving forward, CMMI plansto increase stakeholder perspectives and feedback on model
`successesand challengesvia listening sessions hosted throughout the year—thefirst of
`which took place on November18.
`
`During this session, Lalan Wilfong, MD,vice president of care relations and practice
`transformation at McKesson and a medical oncologist and hematologist at Texas Oncology,
`laid out some complications of OCM and subsequent RO modelparticipation.
`
`Wilfong discussed howthesepractices will have to submit data for the mandatory RO
`model througha different platform than that used for OCM.This inconsistency presents a
`hurdle for practices as it took some years to optimize data reporting procedures to minimize
`compliance burdens.
`
`With a new data reporting format under the RO model, “it feels like we have to start over
`again,” Wilfong said. But improved alignment from CMMI in the future mayhelp alleviate
`these challenges and enable modelparticipation, he added.
`
`Touching on the heterogeneity of cancer care, Wilfong explained how historical benchmarks
`maynot accurately reflect the current care provided. For example, at the start of the OCM,
`lung cancercare was“very simple in the managementat that time,” but over the past few
`years, has seen “tremendousinnovation.”
`
`“My care pathsfor patients with lung cancer are very complex now, where they used to be
`pretty simple, with very different costs and outc